Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)

Coronary Artery Disease Clinical Trial

— COGENT-1  

Official title:

A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00557921
• Other study ID #: CG104
• Secondary ID: EudraCT 2007-005
• Status: Terminated
• Phase: Phase 3
• First received: November 12, 2007
• Last updated: January 27, 2009
• Start date: December 2007
• Est. completion date: November 2009

Study information

• Verified date: January 2009
• Source: Cogentus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBulgaria: Bulgarian Drug AgencyChile: Instituto de Salud Pública de ChileCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySlovakia: State Institute for Drug ControlUkraine: State Pharmacological Center - Ministry of HealthItaly: Ethics CommitteeMexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial Summary

The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy.

Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens.

The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease.

Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5000
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patients in whom a requirement for clopidogrel therapy with concomitant aspirin is anticipated for at least the next 12 months. Specific conditions that may confer a need for long-term clopidogrel + aspirin therapy may include non-ST segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), ST segment elevation acute MI), or new placement of a coronary artery stent.

• For women of childbearing potential, negative pregnancy test prior to randomization and agreement to use effective method of birth control during the study.

• Able to provide written informed consent based on competent mental status.

Exclusion Criteria:

• Patients currently hospitalized for whom discharge is not anticipated within 48 hours of randomization.

• Requirement for current or chronic use of a proton pump inhibitor, H2 receptor blocker, sucralfate or misoprostol.

• Erosive esophagitis, esophageal or gastric variceal disease, or non-endoscopic gastric surgery. Patients with a history of GERD/erosive esophagitis or dyspepsia who do not currently require proton pump blockers will be eligible.

• Receipt of > 21 days of clopidogrel or another thienopyridine prior to randomization.

• Oral anticoagulation that cannot be safely discontinued for duration of study.

• Recent fibrinolytic therapy.

• Scheduled percutaneous coronary intervention (PCI). Patients may be enrolled upon completion of PCI.

• Recent (< 30 days prior to randomization) or scheduled coronary artery bypass graft (CABG) surgery.

• Cardiogenic shock at time of randomization, refractory ventricular arrhythmias, or congestive heart failure (NY Heart Association class IV).

• Active pathological bleeding or a history of hereditary or acquired hemostatic disorder.

• History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm.

• Systemic corticosteroids except low-dose oral corticosteroids equivalent to prednisone < or equal to 5 mg/day.

• Allergy or contraindication to clopidogrel or other thienopyridine drugs, omeprazole or other proton pump inhibitor drugs, aspirin or salicylate derivatives, or other study drug ingredients.

• Treatment within 30 days prior to randomization with any investigational drug or device including investigational coronary artery stents or currently enrolled in another interventional drug or device study.

• Women who are pregnant or breastfeeding.

• Life expectancy less than 12 months.

• Laboratory abnormality at screening that is clinically significant or outside protocol-allowed limits, or any other condition that precludes participation in the study in the opinion of the Investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Drug:
• CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin
(CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
• Plavix (clopidogrel 75 mg) and aspirin
(CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)

Locations

Country	Name	City	State
Australia	Wesley research institute	Auchenflower	Queensland
Australia	Cairns Base Hospital	Cairns	Queensland
Australia	Coffs Harbour Cardiology	Coffs Harbour	New South Wales
Australia	Cardiac Research Institute	Eastwood	New South Wales
Australia	Northern Hospital	Epping	Victoria
Australia	St.Vincent's Hospital (Melb)	Fitzroy	Victoria
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	The Canberra Hospital	Garran	Australian Capital Territory
Australia	Geelong Hospital- Barwon Health	Geelong	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Launceston General Hospital	Launceston	Tasmania
Bulgaria	Multiprofile Hospital for Active Treatment "Sveta Ekaterina", 1st Department of Internal Diseases	Dimitrovgrad
Bulgaria	Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski, Clinic of Cardiology	Pleven
Bulgaria	Multiprofile Hospital for Active Treatment ''Sveti Georgi'', Cardiology Clinic	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment ''Sveti Panteleymon'', 2nd Department. of Internal Diseases - Intensive Cardiology Unit	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment - Ruse, 4th Department of Internal Diseases	Rousse
Bulgaria	4th Multiprofile Hospital for Active Treatment	Sofia
Bulgaria	Military Medical Academy, Clinic of Cardiology and Intensive Care	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov". Cardiology Clinic	Sofia
Bulgaria	National Heart Hospital Department of Cardiology	Sofia
Bulgaria	National Multiprofile Transport Hospital "Tsar Boris III, Cardiology Clinic	Sofia
Bulgaria	Tokuda Hospital Department of Cardiology	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment ''Tsaritsa Ioanna'' - ISUL, Cardiology Clinic	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Internal Diseases - 2nd Internal Department	Varna
Canada	Cambridge Cardiac Care Centre	Cambridge	Ontario
Canada	Recherches Cliniques Theradev	Granby	Quebec
Canada	ViaCar Recherche Clinique Inc.	Greenfield Park	Quebec
Canada	ViaCar Recherche Clinique Inc	Longueuil	Quebec
Canada	Dr. Tsui	Maple Ridge	British Columbia
Canada	Mississauga Clinical Research Center	Mississauga	Ontario
Canada	South East Regional Health Authority	Moncton	New Brunswick
Canada	Hospitalier de l'Universite de Montreal Hotel Dieu	Montreal	Quebec
Canada	Sacre-Coeur Hospital	Montreal	Quebec
Canada	Commonwealth Medical Clinic	Mount Pearl	Newfoundland and Labrador
Canada	Fraser Clinical Trials Inc and Royal Columbian Hospital	New Westminster	British Columbia
Canada	Dr. George Zimakas	Niagara Falls	Ontario
Canada	Dr. James Y. Cha	Oshawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec (CHOQ) Hotel Dieu de Quebec	Quebec
Canada	Laval Hospital	Quebec
Canada	Centre de Sante et de services sociaux du nord de lanaudiere/CHRDL	St. Charles-Borromee	Quebec
Canada	Centre Hospitalier Beauce-Etchemin	St. George	Quebec
Canada	Curans Health Center	Thunder Bay	Ontario
Canada	Toronto East Cardiology Associates Inc.	Toronto	Ontario
Canada	Clinique de Cardiologie de Trois-Rivieres	Trois Rivieres	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia
Canada	Cardiology and Research	Westmount	Quebec
Canada	Health Sciences Centre	Winnipeg	Manitoba
Chile	Clinica Antofagasta	Antofagasta
Chile	Corporación de Beneficencia Osorno	Osorno
Chile	Hospital Regional de Punta Arenas Dr. Lautaro Navarro	Punta Arenas
Chile	Complejo Asistencial Dr.Sótero del Río	Santiago
Chile	Hospital del Salvador	Santiago
Chile	Instituto Nacional del Tórax	Santiago
Chile	Centro de Estudios Cardiovascular	Temuco
Chile	Clínica Reñaca	Viña del Mar
Chile	Hospital Dr. Gustavo Fricke	Viña del Mar
Chile	Hospital Naval Almirante Neff	Viña del Mar
Czech Republic	Nemocnice ve Frydku-Mistku	Frydek-Mistek
Czech Republic	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czech Republic	Krajska nemocnice Liberec, a. s.	Liberec
Czech Republic	Litomyslska nemocnice a. s.	Litomysl
Czech Republic	Kardiologická ambulance	Ostrava
Czech Republic	Kardiologicka a angiologicka ambulance	Ostrava Vítkovice
Czech Republic	Pardubicka krajska nemocnice, a.s.	Pardubice
Czech Republic	II.interni klinika kardiologie a angiologie 1. LF UK a VFN v Praze	Praha 2
Czech Republic	Klinika kardiologie Institut klinické a experimentální medicíny	Praha 4
Czech Republic	Krajská nemocnice T. Bati a.s.	Zlín
Czech Republic	Nemocnice Znojmo, p.o.	Znojmo
France	Centre Hospitalier d'Albi	Albi
France	Centre de Cardiologie CHRU Dijon	Dijon Cedex
France	Clinique Pasteur	Essey les Nancy Cedex
France	CHRU de Lille Hôpital Cardiologique	Lille Cedex
France	Hôpital La Timone-Adultes	Marseille
France	Hôpital Lariboisière	Paris
France	La Pitié Salpétrière Institut de Cardiologie	Paris Cedex 13
France	Centre Hospitalier Intercommunal du Val d'Ariège	St Jean de Verges
France	Centre Hospitalier Rangueil Larrey	Toulouse Cedex 4
Germany	Universitatsklinikum Berlin Campus Charite Mitte Med Klinik Kardiologie und Angiologie	Berlin
Germany	Vivantes Clinic Neuköln Berlin	Berlin
Germany	Vivantes Humbolt Klinikum	Berlin
Germany	Praxis Dr. med. Boscher	Biberach
Germany	St. Josef-Hospital Medizinische Klinik II, Kardiologie	Bochum
Germany	St.-Marien-Hospital Bonn	Bonn
Germany	Dr. THomas Klingenheben	Bonn-Lengsdorf
Germany	Städtisches Klinikum Brandenburg GmbH	Brandenburg
Germany	MVZ am Küchwald GmbH	Chemnitz
Germany	Gemeinschaftspraxis Innere Medizin und Kardiologie	Dinslaken
Germany	St.-Johannes-Hospital Dortmund	Dortmund
Germany	Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR	Dresden
Germany	Practice of Cardiology	Erfurt
Germany	Elisabeth.Krankenhaus	Essen
Germany	Asklepios Klinik Barmbek	Hamburg
Germany	Asklepios Klinik St.Georg	Hamburg
Germany	Kardiologische Praxis Hamburg Altona	Hamburg
Germany	Universitäres Herz-und Gefäßzentrum Hamburg"	Hamburg
Germany	Klinikum Region Hannover Krankenhaus Nordstadt	Hannover
Germany	Kardiologische Gemeinschaftspraxis	Hartmannsdorf
Germany	SRH Klinikum Karlsbad-Langensteinbach	Karlsbad
Germany	Kliniken der Stadt Köln, Köln Merheim	Koln
Germany	Herzzentrum Lahr	Lahr
Germany	Kardiologische Gemeinschaftpraxis	Leipzig
Germany	Universität Leipzig - Herzzentrum	Leipzig
Germany	Universitätsklinikum Lübeck	Lübeck
Germany	Praxis für Innere Medizin, Gastroenterologie	Ludwigshafen
Germany	Gemeinschaftspraxis	Lüneburg
Germany	Klinikum der Johannes-Gutenberg-Universität	Mainz
Germany	Gemeinschaftspraxis	Mannheim
Germany	Klinikum Mannheim GmbH, Universaitatskinikum	Mannheim
Germany	Kardiologische Praxis	Markkleeberg
Germany	Asklepios Klinik Melsungen	Melsungen
Germany	Kilniken Maria Hilf GmbH Krankenhaus St. Franziskus	Mönchengladbach
Germany	Internist/Kardiologe/Angiologe	Mühldorf a.d. Inn
Germany	Kardiologische Gemeinschaftspraxis	Nienburg
Germany	Klinikum Pirna GmbH	Pirna
Germany	Universitätsklinik Regensburg	Regensburg
Germany	Krankenhaus Reinbek St. Adolf-Stift	Reinbek
Germany	Kardiologische Gemeinschaftspraxis	Riesa
Germany	Internistische Praxis	Rottweil
Germany	Zentrum für Prävention und Rehabilation	Siegen
Germany	Marienkrankenhaus Soest	Soest
Germany	Praxisgemeinschaft Stuhr-Brinkum	Stuhr
Germany	Medizinische Universitätsklinik	Tubingen
Germany	Josephs-Hospital Warendorf	Warendorf
Germany	Kardiologische Praxis	Wermsdorf
Germany	Dr. Andreas Schreckenberg	Weyhe-Leeste
Germany	ForschungsZentrum Ruhr	Witten
Germany	Helios Klinikum Wuppertal	Wuppertal
Hungary	Bajai Kórház	Baja
Hungary	Budai Irgalmasrendi Kórház	Budapest
Hungary	Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet	Budapest
Hungary	Fovárosi Önkormányzat Károlyi Sándor Kórház és Rendelointézet	Budapest
Hungary	Városi Önkormányzat Kórház-Rendelointézet	Kalocsa
Hungary	Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház	Nyíregyháza
Hungary	Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház	Toszegi
Hungary	Jávorszky Ödön Kórház	Vác
Hungary	Zala Megyei Kórház	Zalaegerszeg
Italy	Ospedali Riuniti di bergamo	Bergamo
Italy	Azienda Ospedaliera della Provincia di Lodi Presidio Ospedaliero di Codogno	Codogno (Lodi)
Italy	Azienda Ospedaliera Universitaria San Martino-Dipartimento di Medicina Interna e Specialità Mediche	Genova
Italy	Azienda Ospeedaliera Carlo Poma	Mantova
Italy	Azienda Ospedaliera Maggiore Della Carita' Di Novara	Novara
Italy	Istituto Clinico Humanitas	Rozzano (Milano)
Mexico	Hospital Cardiológica Aguascalientes	Aguascalientes
Mexico	Hospital de Jesus	D. F.
Mexico	Cardioprevent	Durango
Mexico	Hospital "Valentín Gómez Farías"	Guadalajara	Jalisco
Mexico	Hospital Angeles de Puebla	Puebla
Mexico	Hospital General de Puebla	Puebla
Mexico	Instituto de Corazón de Querétaro, S.A. de C.V.	Queretaro
Mexico	Cardioarritmias e Investigación, S.C.	San Luis Potosi	San Lusi Potosi
Mexico	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi
Poland	NZOZ "Medicus" Jacek Kubica	Bydgoszcz
Poland	Oddzial Kardiologii z Zakladem Diagnostyki Kardiologicznej, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewódzki Szpital im. dr J. Biziela,	Bydgoszcz
Poland	Wojewódzki Szpital Meijski im. Biziela, Oddzial Kardiologii - SPZOZ	Bydgoszcz
Poland	Oddzial Chorób Wewnetrzych i Kardiologii , ZOZ w Debicy	Debica
Poland	Zaklad Opieki Zdrowotnej Trójmiejskie Centrum Medyczne Sp. z o.o	Gdansk
Poland	Centrum Leczenia Chorób Cywilizacyjnych Oddz. Gdynia filla Fikakowo	Gdynia
Poland	Gabinet Kardiologiczno-Internistyczny	Gdynia
Poland	Gabinet Kardiologiczny Medipuls	Gdynia
Poland	NZOZ Medicus, Poradnia Kardiologiczna	Gliwice
Poland	Oddzial Kardiologii i INK, SPZOZ nr 1	Gliwice
Poland	Mazowieckie Centrum Badan Klinicznych Iwona Czajkowska, Monika Smietanska s.c.	Grodzisk Mazowiecki
Poland	Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej Oddzial Kardiologiczny	Inowroclaw
Poland	Oddzial Chorób Wewnetrznych i Farmakologii Klinicznej Samodzielny Publiczny Centralny Szpital Kliniczny im. Prof. Kornela Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach	Katowice
Poland	Szpital Specjalistyczny w Koscierzynie, Oddzial Kardiologii	Koscierzyna
Poland	"Klinika Choroby Wiencowej Instytut Kardiologii, Collegium Medicum Uniwerytet Jagiellonski	Krakow
Poland	Oddzial Kardiologii, Szpital Specjalistyczny im. J. Dietla	Krakow
Poland	Oddzial Chorób Wewnetrznych III Szpital Specjalistyczny im.Stefana Zeromskiego, SPZOZ w Krakowie	Kraków
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Specjalista Sp. z o.o.	Kutno
Poland	Poradnia Kardiologiczna, Oddzial Chorob Wewnetrznych Szpital Powiatowy w Limanowej	Limanowa
Poland	All-Med Centrum Medyczne	Lódz
Poland	Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA	Lódz
Poland	Oddzial Kardiologiczny Szpital Wojewódzki im. Kardynala Stefana Wyszynskiego	Lomza
Poland	Oddzial Internistyczno-Kardiologiczny Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Lubartów
Poland	"Oddzial Chorob Wewnetrznych i Kardiologii, Szpital Powiatowy im.Edmunda Biernackiego	Mielec
Poland	Oddzial Kardiologii, Nowa Sól	Nowa Sól
Poland	ZOZ w Olawie, Oddzial Chorób Wewnetrznych	Olawa
Poland	"Oddzial Kardiologiczno-Internistyczny	Olsztyn
Poland	"Oddzial Kardiologiczny Publiczny Samodzielny ZOZ Wojewódzkie Centrum Medyczne	Opole
Poland	Specjalistyczny Zaklad Opieki Zdrowotnej Poradnia lekarzy specjalistów "Jantar"	Ostrów Wielkopolski
Poland	II Oddzial Wewnetrzny Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Pabianice
Poland	"Samodzielny Szpital Wojewódzki im. Mikolaja Kopernika, Oddzial Kardiologiczny	Piotrków Trybunalski
Poland	Specjalistyczna Przychodnia Lekarska "Medikard"	Plock
Poland	Wojewódzki Szpital Zespolony, Oddzial Kardiologiczny	Plock
Poland	Medyczne Centrum Hetmanska, Indywiualna Specjalistyczna Praktyka Lekarska, Dr n. med. Piotr Leszczynski	Poznan
Poland	Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwór	Poznan
Poland	Oddzial Wewnetrzny I, Szpital Kolejowy im. dr med. Wlodzimierza Roeslera	Pruszków
Poland	Samodzileny Publiczny Zaklad Opieki Zdrowotnej w Pulawach, Szpital Specjalistyczny	Pulawy
Poland	Zaklad Hemodynamiki, Wojewódzki Szpital Specjalistyczny	Radom
Poland	"Oddzial Kardiologii z Pododdzialem Ostrych Zespolów Wiencowych i z Osrodkiem Implantacji Rozruszników Serca,	Rzeszów
Poland	Oddzial Kardiologii, SP ZZOZ Sandomierz	Sandomierz
Poland	Oddzial Kardiologiczny Wojewódzki Szpital Specjalistyczy w Siedlcach	Siedlce
Poland	Oddzial Kardiologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Sieradzu im. Kardynala Stefana Wyszynskiego	Sieradz
Poland	"Oddzial Kardiologii, Wojewódzki Szpital Zespolony w Skierniewicach, "	Skierniewice
Poland	NZOZ Przychodnia Zadebie, Przychodnia Kardiologiczna	Skierniewice
Poland	"Oddzial Kardiologii Inwazyjnej i Angiologii z Pr. Hemodynamiki	Stalowa Wola
Poland	Szpital Specjalistyczny Sw.Jana, Oddzial Kardiologii,	Starogard Gdanski
Poland	Indywidualna Specjalistyczna Praktyka Lekarska	Szczecin
Poland	Poradnia Kardiologiczna	Tarnów
Poland	Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny-Cardiology	Tarnów
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz", Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna	Torun
Poland	Oddzial Kardiologii Wojewódzki Szpital Zespolony	Torun
Poland	"Oddzial Kardiologiczny Walbrzyski Osrodek Kardiologii Interwencyjnej Specjalityczny Szpital im. Dr Alfreda Sokolowskiego	Walbrzych
Poland	Centrum Leczenia Chorób Cywilizacyjnych	Warszawa
Poland	II Klinika Choroby Wiencowej Instytutu Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego	Warszawa
Poland	Miedzyleski Szpital Specjalistyczny w Warszawie	Warszawa
Poland	NZOZ Starówka	Warszawa
Poland	Oddzial Kardiologiczny Szpital Wolski im. dr Anny Gostynskiej Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Warszawa
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny Akademii Medycznej w Warszawie	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej, Centrum Badan Klinicznych	Wroclaw
Poland	Osrodek Chorob Serca, Klinika Kardiologii 4 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Wroclaw
Poland	Synexus SCM Sp.z o o.	Wroclaw
Poland	"Slaskie Centrum Chorób Serca, III Katedra i Oddzial Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego	Zabrze
Puerto Rico	Research and Cardiovascular Corp.	Ponce
Romania	Spitalul Clinic Judetean de Urgenta Bacau	Bacau
Romania	Cardiomed SRL	Bucharest
Romania	S.C. Duo Medical S.R.L.	Bucharest
Romania	Centrul Medical SANA	Bucuresti
Romania	Institutul Inimii "Niculae Stanicioiu"	Cluj-Napoca
Romania	Cardiomed SRL	Craiova
Romania	Dr. C.I. Parhon Hospital	Iasi
Romania	Clinical county Hospital	Sibiu
Romania	Institutul de Boli Cardiovasculare si Transplan Tg. Mures	Targu Mures
Romania	County Hospital	Timisoara
Slovakia	Žilpo s.r.o.	Žilina
Slovakia	Medivasa s.r.o.	Žilina
Slovakia	Novamed s.r.o.	Banská Bystrica
Slovakia	Alian s.r.o.	Bardejov
Slovakia	5. Interna klinika LF UK, FNsP Bratislava, Nemocnica Ruzinov	Bratislava
Slovakia	Cardio D&R spol. s r.o.	Kosice
Slovakia	Kardiomed s.r.o.	Lucenec
Slovakia	NZZ Kardiocentrum Nitra s.r.o.	Nitra
Slovakia	MUDr. Tibor DURIS, CSc., s.r.o.	Nove Zamky
Slovakia	Nemocnica s poliklinikou Považská Bystrica	Považská Bystrica
Slovakia	Fakultna Nemocnica Trencin	Trencin
Ukraine	"Klinichne obyednannia shvydkoi medychnoi dopomogy, m. Dnipropetrovs'k,Dnipropetrovs'ka derzhavna medychna akademiya, kafedra gospital'noi terapii #2	Dnipropetrovsk
Ukraine	Oblasnyi klinichnyi kardiologichnyi dyspanser, m. Ivano-Frankivsk, Ivano-Frankivskyi derzhavnyi medychnyi universytet, kafedra terapii # 3	Ivano-Frankivsk
Ukraine	Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska" AMN Ukrainy, m. Kyiv, viddilenia symptomatychnykh arterial'nykh gipertenziy	Kyiv
Ukraine	Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska", viddil reanimatsii ta intensyvnoi terapii, m. Kyiv	Kyiv
Ukraine	TOV "Kardiologichna klinika "Sertse i sudyny" m. Kyiv	Kyiv
Ukraine	Komunal'na ustanova "Oblasnyi kardiologichnyi dyspanser", viddilenia intensyvnoi terapii, m. Zaporizhzhia	Zaporizhzhya
Ukraine	Kardioarytmologichnyi tsentr Zhytomyrs'koi oblasnoi klinichnoi likarni im. O.F. Gorbachevs'kogo, m. Zhytomyr	Zhytomyr
United States	Abington Medical Specialists	Abington	Pennsylvania
United States	Capital Cardiology Associates	Albany	New York
United States	Alabama Clinical Research Institute, Inc. (ACRI)	Alexander City	Alabama
United States	Cardiology Consultants of Orange County	Anaheim	California
United States	Chest and Critical Care Consultants, A Medical Group	Anaheim	California
United States	Community Clinical Research Center	Anderson	Indiana
United States	Family Health Care Assoc.	Arlington	Texas
United States	Clinical Study Center of Asheville, LLC	Asheville	North Carolina
United States	Cumberland Cardiology	Ashland	Kentucky
United States	McMinn Medical Group (DBA: Athens Medical Group)	Athens	Tennessee
United States	Executive Health and Research Associates, Inc.	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Primary Care Specialists, LLC/ ECAST CT	Atlanta	Georgia
United States	Maine Research Associates	Auburn	Maine
United States	American Health Network	Avon	Indiana
United States	Good Samaritan Hospital (Medstar Health)	Baltimore	Maryland
United States	Bluestem Cardiology Research Dept.	Bartlesville	Oklahoma
United States	Verzosa & Ungab Internal Medicine Associates	Bartlett	Tennessee
United States	Dolby Research, LLC	Baton Rouge	Louisiana
United States	Michigan Cardiovascular Institute	Bay City	Michigan
United States	Southeast Texas Clinical Research Center	Beaumont	Texas
United States	Tri-State Medical Group	Beaver	Pennsylvania
United States	Bend Memorial Clinic	Bend	Oregon
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Birmingham Heart Clinic, PC	Birmingham	Alabama
United States	Cardio-Thoracic Surgeons P.C.	Birmingham	Alabama
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	George G. Ellis, Jr. M.D., Inc.	Boardman	Ohio
United States	Connecticut Clinical Research	Bridgeport	Connecticut
United States	Cardiac Care and Vascular Medicine, Albert Einstein College of Medicine	Bronx	New York
United States	Clinical Solutions Advantage	Buena park	California
United States	Daniel W. Gottlieb, MD, PS	Burien	Washington
United States	Kernodle Clinic, Inc.	Burlington	North Carolina
United States	Heritage Cardiology Association	Camp Hill	Pennsylvania
United States	Cardiovascular Research Institute, LLC	Canton	Ohio
United States	Trinity Hypertension and Diagnostic Res.	Carrollton	Texas
United States	Turns Institute for Clinical Research	Castro Valley	California
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	Associated Cardiovascular Consultants	Cherry Hill	New Jersey
United States	PPS Clinical Research, STL, LLC	Chesterfield	Missouri
United States	Comprehensive Cardiology Consultants, Inc.	Cincinnati	Ohio
United States	Colorado Springs Health Partners	Colorado Springs	Colorado
United States	Midwest Cardiology Research Foundation	Columbus	Ohio
United States	Southeast Regional Research Group	Columbus	Georgia
United States	Oscar R. Guerra, MD PA	Coral Gables	Florida
United States	Hudson Valley Cardiology Group, P.C.	Cortlandt Manor	New York
United States	Georgia Heart Specialists, LLC	Covington	Georgia
United States	New England Center for Clinical Research, Inc	Cranston	Rhode Island
United States	U.T. Southwestern	Dallas	Texas
United States	VA Medical Center	Dallas	Texas
United States	Cardiology Consultants of Danville	Danville	Virginia
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Ialum Clinical Research Center	Decatur	Georgia
United States	Ialum Clinical Research Center	Decatur	Georgia
United States	Ialum Clinical Research Center, LLC	Decatur	Georgia
United States	Deerfield Beach Cardiology Associates	Deerfield Beach	Florida
United States	Duluth Clinic / Saint Marys Medical Center	Duluth	Minnesota
United States	Diversified Research	Durham	North Carolina
United States	Premier Heart Specialists	Easton	Pennsylvania
United States	Indiana Medical Research	Elkhart	Indiana
United States	Cardiovascular Associates of the Delaware Valley, P.A.	Elmer	New Jersey
United States	Heart Specialists of Lancaster	Ephrata	Pennsylvania
United States	Escondido Cardiology Associates	Escondido	California
United States	Welborn Clinic	Evansville	Indiana
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Middle Tennessee Clinical Research	Fayetteville	Tennessee
United States	Apex Medical Research, AMR, Inc.	Flint	Michigan
United States	South Suburban Health Professional Group, PC	Flossmoor	Illinois
United States	Amir Malik Research	Fort Worth	Texas
United States	Prestige Clinical Research	Franklin	Ohio
United States	Triad Research Institute	Galax	Virginia
United States	The University of Texas Medical Branch at Galveston	Galveston	Texas
United States	John F Simmons , MD PC	Geneva	Alabama
United States	Altru Health Systems	Grand Forks	North Dakota
United States	eCast Corporation	Greenbelt	Maryland
United States	New Coast Cardiology Center, PLLC	Gulfport	Mississippi
United States	Cardiovascular Associates of the Delaware Valley, P.A.	Haddon Heights	New Jersey
United States	Dr Jules Cohen	Hallandale	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Empire International Research	Hialeah	Florida
United States	Hillsboro Cardiology, PC	Hillsboro	Oregon
United States	Cardiovascular Consultants of South Florida	Hollywood	Florida
United States	Clinical Research Consultants, Inc.	Hoover	Alabama
United States	Michael A. Frais, Cardiologist, P.A.	Hot Springs	Arkansas
United States	Tri-Lakes Research	Hot Springs	Arkansas
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Century Clinical Research	Houston	Texas
United States	Comprehensive Heart Care, PA	Houston	Texas
United States	East Texas Cardiology PA	Houston	Texas
United States	Office of Amer Zaheer, MD	Houston	Texas
United States	Office of Mizra Basith Baig, MD	Houston	Texas
United States	Office of Salim Gopalani, MD	Houston	Texas
United States	The Heart Center, PC	Huntsville	Alabama
United States	Hutchinson Clinic, P.A.	Hutchinson	Kansas
United States	Indiana Heart Physicians	Indianapolis	Indiana
United States	Research Associates of Jackson and Apex Cardiology	Jackson	Tennessee
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Jacksonville Heart Center	Jacksonville	Florida
United States	Jacksonville Heart Center	Jacksonville	Florida
United States	Pennsylvania Heart and Vascular Group, P.C.	Jenkintown	Pennsylvania
United States	Cardiology Associates, P.C.	Johnson City	New York
United States	Tri-State Cardiology	Johnson City	Tennessee
United States	NEA-Clinic Cardiology	Jonesboro	Arkansas
United States	CVMS Resesarch Institute, LLC	Jupiter	Florida
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Glacier View Cardiology	Kalispell	Montana
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Accurate Clinical Trials, Inc.	Laguna Hills	California
United States	Therapeutic Research Institute of Orange County	Laguna Hills	California
United States	Watson Clinic Center for Research	Lakeland	Florida
United States	Kirtik Thaker MD	Lakewood	California
United States	Comprehensive Cardiology Consultants	Langhorne	Pennsylvania
United States	Nevada Cardiology Associates	Las Vegas	Nevada
United States	Sewickley Valley Medical Group Cardiology	Leetsdale	Pennsylvania
United States	Los Angeles Cardiology Associates	Los Angeles	California
United States	Covenant Cardiology Associates	Lubbock	Texas
United States	Wisconsin Heart, S.C.	Madison	Wisconsin
United States	Trover Health System	Madisonville	Kentucky
United States	Heart Clinic of Louisiana Clinical Research, LLC.	Marrero	Louisiana
United States	South Texas Institutes of Health	Mcallen	Texas
United States	Alpha Medical Research, LLC	Melbourne	Florida
United States	Consultants in Cardiovascular Medicine	Melrose Park	Illinois
United States	Goodlife Medical Center	Memphis	Tennessee
United States	Memphis Internal Medicine	Memphis	Tennessee
United States	Merced Heart Associates	Merced	California
United States	Advanced Cardiac Specialists	Mesa	Arizona
United States	Cardiovascular Research Center of South Florida	Miami	Florida
United States	Empire International Research	Miami	Florida
United States	Empire International Research	Miami	Florida
United States	Research Center Phase I-IV of Florida Corp.	Miami	Florida
United States	Suncoast Research Group, LLC	Miami	Florida
United States	Michigan Cardiovascular Institute	Midland	Michigan
United States	Heart Care Associates, LLC	Milwaukee	Wisconsin
United States	Long Island Heart Associates	Mineola	New York
United States	University of Minnesota	Minneapolis	Minnesota
United States	Trinity Health	Minot	North Dakota
United States	Venture Resource Group, Inc.	Mission	Kansas
United States	Mission Internal Medical Group	Mission Viejo	California
United States	Saint Patrick Hospital- International Heart Institute of Montana	Missoula	Montana
United States	Mobile Heart Specialists, PC	Mobile	Alabama
United States	Altos Cardiovascular Associates	Mountain View	California
United States	Lahey Cardiology @ the Medical Center	Nashua	New Hampshire
United States	Heart and Vascular Clinic	Nashville	Tennessee
United States	Charles River Medical Associates	Natick	Massachusetts
United States	Slocum-Dickson Medical Group, PLLC	New Hartford	New York
United States	Sound Shore Cardiology, P.C.	New Rochelle	New York
United States	Bert Fish Medical Center	New Smyrna Beach	Florida
United States	New York Cardiovascular Associate	New York	New York
United States	St. Luke's- Roosevelt Hospital	New York	New York
United States	Alfieri Cardiology, PA	Newark	Delaware
United States	Cardiology Consultants of Philadelphia	Norristown	Pennsylvania
United States	Kenneth W. Carr, MD, Cardiology	Oceanside	California
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	The Creighton Cardiac Center	Omaha	Nebraska
United States	Cardiology Assocaites of Orlando d/b/a Orlando Heart Center	Orlando	Florida
United States	Central Florida Cardiology Group	Orlando	Florida
United States	Midwest Cardiology Assocaites	Overland Park	Kansas
United States	Owensboro Heart and Vascular	Owensboro	Kentucky
United States	Cardiovascular Care of Northern Carolina	Oxford	North Carolina
United States	Sunset Point Medical Associates	Palm Harbor	Florida
United States	Alegent Health Clinic Heart and Vascular Specialist	Papillion	Nebraska
United States	Parkersburg Cardiology Associates	Parkersburg	West Virginia
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Cardiology Consultants of Philadelphia	Philadelphia	Pennsylvania
United States	Cardiology Consultants of Philadelphia	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania Cardiology Department	Philadelphia	Pennsylvania
United States	Cardiovascular Consultants, Ltd.	Phoenix	Arizona
United States	Redpoint Research	Phoenix	Arizona
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Texas Regional Heart Center d/b/a Legacy Heart Center	Plano	Texas
United States	Berma Research Group	Plantation	Florida
United States	Charlotte Heart Group Research Center	Port Charlotte	Florida
United States	Legacy Clinical Research	Portland	Oregon
United States	Rhode Island Hospital Cardiology	Providence	Rhode Island
United States	Rancho CucamongaClinical Trials	Rancho Cucamonga	California
United States	Virginia Cardiovascular Specialists	Richmond	Virginia
United States	Rochester General Hospital	Rochester	New York
United States	Covenant Medical Center, Inc.	Saginaw	Michigan
United States	Michigan Cardiovascular Institute	Saginaw	Michigan
United States	Atlantic Cardiology Associates, P.A	Salisbury	Maryland
United States	Peninsula Cardiology Associates	Salisbury	Maryland
United States	Cardiology Clinic of San Antonio	San Antonio	Texas
United States	Heart & Vascular Institute of Texas	San Antonio	Texas
United States	IMED Research, PA	San Antonio	Texas
United States	South Texas Cardiovascular Consultants	San Antonio	Texas
United States	Inland Heart and Vascular Medical Associates	San Bernardino	California
United States	Ritchken and First	San Diego	California
United States	Richard Levy, MD.	San Francisco	California
United States	Rider Research Group	San Francisco	California
United States	Kaiser Permanente	San Jose	California
United States	Medical Helping Hands Research	Santa Ana	California
United States	Pacific Heart Institute	Santa Monica	California
United States	Radiant Research	Santa Rosa	California
United States	Saratoga Cardiology Assoc, PC	Saratoga Springs	New York
United States	Southeast Regional Research Group	Savannah	Georgia
United States	Cardiovascular Consultants of Maine, PA	Scarborough	Maine
United States	Westchester Cardiology Associates	Scarsdale	New York
United States	Advanced Cardiology Specialists	Scranton	Pennsylvania
United States	Searcy Medical Center	Searcy	Arkansas
United States	Elite Medical Research, Inc.	Sellersville	Pennsylvania
United States	Cardiovascular Associates of the Delaware Valley, P.A.	Sewell	New Jersey
United States	Cochise Clinical Research	Sierra Vista	Arizona
United States	Maine Cardiology Associates	South Portland	Maine
United States	Heart Clinic Northwest	Spokane	Washington
United States	Inland Cardiology Assocaites	Spokane	Washington
United States	Academic Heart and Vascular PLLC	St. Clair Shores	Michigan
United States	Cardiology Diagnostics, Ltd.	St. Louis	Missouri
United States	Regions Hospital	St. Paul	Minnesota
United States	Suncoast Cardiovascular Research	St. Petersburg	Florida
United States	The Heart and Vascular Institute of Florida	St. Petersburg	Florida
United States	Medsouth Primary CareStockbridge	Stockbridge	Georgia
United States	Good Samaritan Hospital	Suffern	New York
United States	Southwest Health Associate, PA	Sugar Land	Texas
United States	Office of Dwayne O. Williams, MD	Sugarland	Texas
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Cardiology, PC	Syracuse	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Franciscan Health System dba FHS Research Center	Tacoma	Washington
United States	Kings Daughters Clinic	Temple	Texas
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Physicans Research Center, LLC	Toms River	New Jersey
United States	Harbor- UCLA Medical Center	Torrance	California
United States	Capital Cardiology Associates	Troy	New York
United States	Oakland Medical Center	Troy	Michigan
United States	Paradigm Clinical Research, Inc.	Tucson	Arizona
United States	Cardiology Consultants of Philadelphia	Upland	Pennsylvania
United States	Ventura Cardiology Consultants Medical Group, Inc.	Ventura	California
United States	G&G Research Baker-Tombul Cardiology	Vero Beach	Florida
United States	Victoria Heart and Vascular Center	Victoria	Texas
United States	Washington V.A. Medical Center	Washington	District of Columbia
United States	Waterford Medical Assoc. P.C.	Waterford	Michigan
United States	Northeast Iowa Medical Education Foundation	Waterloo	Iowa
United States	West Chester Cardiology, PC	West Chester	Pennsylvania
United States	Cardiology Specialists	Westerly	Rhode Island
United States	Carlos Levy, D.O.	Weston	Florida
United States	Buffalo Cardiology and Pulmonary Associates	Williamsville	New York
United States	Mark J. Kozinn, MD	Williamsville	New York
United States	Winchester Medical Center/ Clinical Research Department	Winchester	Virginia
United States	Berks Cardiology, Ltd.	Wyomissing	Pennsylvania
United States	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania
United States	Michigan Heart, PC	Ypsilanti	Michigan
United States	Aquilo Research	Yukon	Oklahoma
United States	Cardiology Associates of SE Ohio, Inc	Zanesville	Ohio
United States	Physicans Research, Inc.	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cogentus Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Chile,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Mexico,  Poland,  Puerto Rico,  Romania,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation		Anticipated minimum of 48 weeks, up to end of study	No
Secondary	Composite of gastroduodenal bleeding, symptomatic gastroduodenal ulcer, obstruction or perforation		Anticipated minimum of 48 weeks, up to end of study	No
Secondary	Composite of gastroduodenal bleeding, obstruction or perforation		Anticipated minimum of 48 weeks, up to end of study	No
Secondary	Discontinuation of study medication attributed to gastrointestinal signs or symptoms		Anticipated minimum of 48 weeks, up to end of study	No
Secondary	Gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis		Anticipated minimum of 48 weeks, up to end of study	No
Secondary	Dyspepsia, defined as an increase of at least ten points on the "pain intensity" component of the SODA instrument from baseline		Anticipated minimum of 48 weeks, up to end of study	No
Secondary	Occurrence of a cardiovascular event (cardiovascular death, nonfatal myocardial infarction, CABG or PCI, or confirmed ischemic stroke		Anticipated minimum of 48 weeks, up to end of study	Yes