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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01425359
Other study ID # GS-US-259-0133
Secondary ID
Status Completed
Phase Phase 4
First received August 24, 2011
Last updated October 30, 2014
Start date September 2011
Est. completion date October 2012

Study information

Verified date October 2014
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health CanadaCanada: Ethics Review CommitteeBelarus: Ministry of HealthCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlGeorgia: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionIsrael: Ethics CommissionIsrael: Ministry of HealthPoland: Ethics CommitteePoland: The Central Register of Clinical TrialsRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSerbia: Ethics CommitteeUkraine: Ethics CommitteeUkraine: Ministry of HealthRomania: Ethics CommitteeRomania: National Medicines AgencySlovak Republic: Ethics CommitteeSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics CommitteeBulgaria: Bulgarian Drug AgencyBulgaria: Ethics committee
Study type Interventional

Clinical Trial Summary

This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to record their daily angina episodes in a diary at the end of each study day. Ranolazine is approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.


Description:

Participants who meet the eligibility criteria at screening will enter a 4-to 6-week Qualifying Period. The allowed concomitant antianginal medication(s) must be maintained at a stable dose throughout the study. Participants will document the number of angina episodes, number of sublingual nitroglycerin doses taken, and a dyspnea score (on a scale from 1 to 5) on a daily basis in a diary. Participants eligible to stay in the study after the Qualifying Period will enter the 8-week double-blind dosing phase. Participants will have study visits at the end of Weeks 2 and 8. Participants will continue to document the number of angina episodes and number of sublingual nitroglycerin doses taken as well as a dyspnea score on a daily basis by the end of each day in their diary. In addition, participants will be called during Week 2 and at the end of Week 5 to encourage compliance. A safety follow-up phone call will be made 14 days after the last study visit or early discontinuation.


Recruitment information / eligibility

Status Completed
Enrollment 949
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent

- Males and females aged at least 18 years

- At least a 3-month history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin

- CAD documented by one or more of the following:

1. Angiographic evidence of = 50% stenosis of one or more major coronary arteries

2. History of myocardial infarction (MI) documented by positive myocardial muscle creatine kinase (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes

3. Cardiac imaging study or exercise test diagnostic for CAD

- Treatment with up to 2 antianginal therapies at a stable dose for at least 2 weeks prior to the Qualifying Period.

- Documented history of T2DM

- Willing to maintain stable tobacco usage habits throughout the study

- Willing to maintain stable activity levels throughout the study

- Females of childbearing potential must agree to utilize highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.

Exclusion Criteria:

- New York Heart Association (NYHA) Class III and IV

- Acute coronary syndrome in the prior 2 months or planned coronary revascularization during the study period

- Stroke or transient ischemic attack within 6 months prior to Screening

- QTc > 500 milliseconds

- Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg)

- Systolic blood pressure < 100 mmHg

- Clinically significant hepatic impairment

- Prior treatment with ranolazine, or known hypersensitivity or intolerance to ranolazine

- Females who are breastfeeding

- Positive serum pregnancy test

- Participation in another investigational drug or device study within 1 month prior to Screening

- Current treatment with trimetazidine, ivabradine, or nicorandil. Subjects will need to discontinue these medications 2 weeks prior to the Qualifying Period.

- Current treatment with potent inhibitors of cytochrome (CYP)3A (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)

- Current treatment with CYP3A and P glycoprotein (Pgp) inducers (eg, rifampicin/rifampin, carbamazepine, and St. John's wort [Hypericum perforatum])

- Current treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, and sirolimus)

- Subjects taking simvastatin who cannot reduce the dose to 20 mg once daily or who cannot switch to another statin

- Current treatment with Class I or III antiarrhythmic medications

- History of illicit drug use or alcohol abuse within 1 year of Screening

- Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study

Study Design

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


Intervention

Drug:
Ranolazine

Ranolazine placebo


Locations

Country Name City State
Belarus State Institution "Gomel regional clinical hospital" Gomel
Belarus State Inst Rep Scientific and Practical center Minsk
Bulgaria Diagnostic Consultative Center, Ascendent Cardiological Out-Patient Office Sofia
Bulgaria MHAT "Tsar Boris III" Sofia
Bulgaria MHAT "Vita", Cardiology Department Sofia
Bulgaria Military Medical Academy, Clinic of Cardiology and Intesive Care Sofia
Bulgaria National Cardiology Center, Cardiology Clinic - III Sofia
Bulgaria UMHAT "Tsaritsa Yoanna" - ISUL, Cardiology Clinic Sofia
Canada High Desert Medical Group Lancaster
Canada Montréal General Hospital Montreal Quebec
Canada Montreal Heart Institute Montreal
Canada SKDS Research Inc New Market Ontario
Canada London Road Diagnostic Clinic and Medical Centre Ontario
Canada Topsail Road Medical Clinic Saint John's
Canada Dr. Roger Labonté Professional Medicine Corp. Sudbury Ontario
Canada Aniol Gupta MD Toronto Ontario
Czech Republic Vojenska Nemocnice Brno Brno
Czech Republic Cardiocentrum Kladno s.r.o. Kladno
Czech Republic Poliklinika Modrany - Kardiologie Praha 4
Czech Republic Corintez s.r.o. Praha 5
Czech Republic Fakultní Nemocnice v Motole Praha 5
Czech Republic Centrum klinického výzkumu, s.r.o. Príbram
Czech Republic Nemocnice Slaný Slaný
Georgia Amtel Hospital First Clinical LLC Tbilisi
Georgia Cardio-Reanimation Clinic LTD Tbilisi
Georgia Clinic "Guli" Tbilisi
Georgia Emergency Cardiology Center by Academician G. Chapidze LTD Tbilisi
Georgia Multiprofile Clinical Hospital of Tbilisi #2 LTD Tbilisi
Georgia Tbilisi Heart and Vascular Clinic LTD Tbilisi
Georgia Tbilisi State Medical University Alexandre Aladashvili University Clinic Tbilisi
Germany Charité Campus Virchow Klinikum Berlin
Germany Städtische Kliniken Bielefeld Bielefeld
Germany Sankt Johannes-Hospital Dortmund Dortmund
Germany Universitätsklinikum Göttingen Göttingen
Germany Gemeinschaftspraxis fur Kardiologie Heidelberg
Germany Praxis Fur Innere Medizin Kardiologie, Pneumologic und Allergologie Mannheim
Germany Universitätsmedizin Mannheim Mannheim
Israel Barzilai Medical Center, Cardiology Dept. Ashkelon
Israel Assaf Harofeh Medical Centre Be'er Ya`aqov
Israel Shaare Zedek Medical Center Jerusalem
Israel Kaplan Medical Center Rehovot
Israel Ziv Medical Center Safed
Israel Tel Aviv Souraski Medical Center Tel Aviv
Poland Pomorskie Centra Kardiologiczne S.A. Gdansk
Poland NZOZ Sródmiescie Sp z o.o. Gdynia Pomorskie
Poland S.P. Specjalistyczny Szpital Zachodni im.JP II Grodzisk, Mazowiecki
Poland Krakowski Szpital Specjalistyczny im.JPII Krakow
Poland NZOZ Revita Poradnia Kardiologiczna Kraków Malopolskie
Poland Specjalistyczna Praktyka Lekarska Leszek Bryniarski Kraków Malopolskie
Poland MULTI-MED PLUS Sp. z o.o. Lódz Lodzkie
Poland KO-MED Marek Konieczny Pulawy Lubelskie
Poland Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Zdrowia "Zadebie" Skierniewice Lodzkie
Poland Centrum Badawcze Wspólczenej Terapii Warszawa
Poland Instytut Kardiologii Warszawa Mazowieckie
Poland Instytut Kardiologii Warszawa Mazowieckie
Poland Synexus SCM Sp. z o.o. Oddzial w Warszawie Warszawa
Poland Slaskie Centrum Chorób Serca w Zabrzu Zabrze
Russian Federation Altay Regional Cardiologycal Dispensary Barnaul
Russian Federation "Chita State Medical Academy" Curative-Diagnostic Clinic department Chita
Russian Federation Sverdlovsky Regional Clinical Hospital of Wars Veterans Ekaterinburg
Russian Federation Municipal Institution of Healthcare "Kemerovo Cardiology Dispensary" Kemerovo
Russian Federation Non-state Institution of healthcare "Department hospital on station Kemerovo of OAO "Russian Railway" Kemerovo
Russian Federation Medical centre "Delis", LLC Kirovsk
Russian Federation City Clinical Hospital named after S.P.Botkin Moscow
Russian Federation Federal State Institution "National Research Center for Preventive Medicine" Moscow
Russian Federation Federal State Institution "Outpatient department #3" of President Management department of Russian Federation Moscow
Russian Federation FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF Moscow
Russian Federation First Moscow State Medical University I.M. Sechenov Moscow
Russian Federation Moscow City Clinical Hospital #51 Moscow
Russian Federation Moscow State Institution of Health "City Clinical Hospital #81" Moscow
Russian Federation Moscow State University of Medicine and Dentistry based on Moscow City Clinical Hospital #71 Moscow
Russian Federation State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department Moscow
Russian Federation State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department Moscow
Russian Federation State healthcare institution of Moscow "City Clinical hospital#15 named after O.M.Filatov" Moscow
Russian Federation State Healthcare institution of Moscow"Cardiology Dispensary #2" Moscow
Russian Federation State Institution of Moscow Healthcare "City Clinical Hospital named after S.P. Botkin" Moscow
Russian Federation State Novosibirsk Regional Clinical Hospital Novosibirsk
Russian Federation Regional Clinical Hospital named after N.N.Burdenko Penza
Russian Federation State Institution of Healthcare Perm Regional Hospital for War Veterans Perm
Russian Federation City Hospital #38 named after Semashko N.A Pushkin St. Petersburg
Russian Federation State Healthcare Institution "Ryazan regional clinical cardiological dispensary" Ryazan
Russian Federation "Clinical hospital named after S.R.Mirotvortsev" Saratov
Russian Federation Educational Institution of Higher Vocational Education "Smolensk State Medical Academy" on the base of Municipal Medicoprophylactic Institution "Hospital of Emergency Medical Care", Smolensk
Russian Federation Federal Heart, Blood and Endocrinology Centre n.a. Almazov St. Petersburg
Russian Federation Federal Heart, Blood and Endocrinology Centre n.a. Almazov St. Petersburg
Russian Federation Federal State Educational Institution of High Professional Education "Military Medical Academy n.a. S.M. Kirov" of the Ministry of Defence of Russia St. Petersburg
Russian Federation FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF St. Petersburg
Russian Federation Institution and Address: "Medical Research Institute", LLC St. Petersburg
Russian Federation International Medical Center "SOGAZ", LLC St. Petersburg
Russian Federation Saint-Petersburg State Healthcare Institution St. Petersburg
Russian Federation State Healthcare institution "Municipal Out-patient Clinic #109" St. Petersburg
Russian Federation State Institution of Healthcare "City Hospital #40 of Kurortniy administrative district St. Petersburg
Russian Federation Autonomous healthcare institution of Voronezh region "Voronezh regional clinic consultative and diagnostic centre" Voronezh
Russian Federation Municipal Institution of Healthcare "Clinical Hospital #8 of Yaroslavl" Yaroslavl
Serbia Cardiology Clinic, Clinical Center Serbia Belgrade
Serbia Institute of Cardiovascular Diseases Sremska Kamenica
Slovakia ALIAN, s.r.o. Bardejov
Slovakia Cardioconsult, s.r.o. Bratislava
Slovakia Kardiovaskulárne centrum, s.r.o. Bratislava
Slovakia CARDIO D&R, s.r.o. Košice
Slovakia KARDIOMED, s.r.o. Lucenec
Slovakia Kardiocentrum Nitra, s.r.o. Nitra
Slovenia University Clinic of Respiratory and Allergic Diseases Golnik Golnik
Slovenia University Klinicni Center Ljubljana Ljubljana
Slovenia General Hospital Murska Sobota Murska Sobota
Ukraine Donetsk National Medical University, Department of Internal Medicine #1 based on Department of Emergency Cardiology and Rehabilitation of Institute of Urgent and Recovery Surgery named after V. K. Gusak Donetsk
Ukraine Central Clinical Hospital of Ukrzaliznitsia, Cardiology department Kharkiv
Ukraine Kharkiv Medical Academy of Postgraduate Education, Department of cardiology and functional diagnostics based on City Clinical Hospital #8, Department of Cardiology #2 Kharkiv
Ukraine Central polyclinic of Pechersk district, Department of cardiology Kyiv
Ukraine Department of Diabetology of National Medical Academy of Postgraduate Education named after P.L.Shupyk based on Day Time Hospital of Administration of Medical Service and Rehabilitation of "ARTEM" SHC Kyiv
Ukraine Kyiv City Clinical Hospital #1, Department of Emergency Cardiology Kyiv
Ukraine Kyiv city clinical hospital #5 Kyiv
Ukraine SI "Institute of Gerontology of AMS of Ukraine" Kyiv
Ukraine Lviv National Medical University named after Danylo Halytsky, Department of Propaedeutics of Internal Medicine #1 based on Polyclinic Department of Municipal City Clinical Hospital #5 Lviv
Ukraine SI Odessa Regional Cardiological Dispensary Odessa
United States Alexandria Cardiology Clinic Alexandria Louisiana
United States Endeavor Medical Research, PLC Alpena Michigan
United States Masters of Clinical Research, Inc. Augusta Georgia
United States Columbus Cardiology Associates Columbus Georgia
United States Cross Country Cardiology Edgewater New Jersey
United States Central Cardiology Associates Elizabethtown Kentucky
United States South Florida Research Solutions, LLC Hollywood Florida
United States Med-Tech Research Houston Texas
United States Humble Cardiology Associates Humble Texas
United States Kore CV Research Jackson Tennessee
United States Baptist Heart Specialist Jacksonville Florida
United States Wellmont Cardiovascular Associates Heart Institute Johnson City Tennessee
United States Cardiology and Medicine Clinic Little Rock Arkansas
United States Clinical Trials Management, LLC Mandeville Louisiana
United States Merced Heart Associates Merced California
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States Spectrum Clinical Research Institute, Inc Moreno Valley California
United States Research Integrity, LLC Owensboro Kentucky
United States Sacramento Heart and Vascular Research Center Sacramento California
United States Clinical Research of Central Florida Winter Haven Florida

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Belarus,  Bulgaria,  Canada,  Czech Republic,  Georgia,  Germany,  Israel,  Poland,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment Average weekly angina frequency was defined as the total number of angina episodes reported during the last 6 weeks of treatment divided by 6 weeks.
For subjects who terminated with less than 6 weeks of treatment, frequency was calculated as the total number of angina episodes reported during the treatment period divided by the subject's actual duration of treatment.
6 weeks No
Secondary Average Weekly Frequency of Sublingual Nitroglycerin Use Over the Last 6 Weeks of Treatment Average weekly frequency of sublingual nitroglycerin use was defined as the total number reported during the last 6 weeks of treatment divided by the duration corresponding to the last 6 weeks of treatment. 6 weeks No
Secondary Percentage of Weeks Participants Achieved at Least a 50% Reduction in Angina Frequency For each participant, the percentage of the last 6 weeks on treatment during which the angina frequency was less than or equal to 50% of the baseline average weekly angina frequency was determined. 6 weeks No
Secondary Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was = 50% of the Baseline Average Weekly Angina Frequency 6 weeks No
Secondary Change From Baseline in the Short-Form 36® (SF-36) Mental and Physical Component Scores The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state. Participants were asked to complete the survey at randomization (prior to receiving treatment), and at end of treatment visit (Week 8) or early study drug discontinuation or early termination visit. The survey asked participants for responses specific to the preceding 4 weeks prior to completing the survey. Up to 8 weeks No
Secondary Patient's Global Impression of Change (PGIC) Scale Score The PGIC was completed at the end of treatment/last visit.The PGIC scale measures the change in the participant's overall status since the beginning of the study on a scale ranging from 1 (no change or worse) to 7 (very much improved). 8 weeks No
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