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NCT00614380 Clinical Trial

Open Label Study Telmisartan and Amlodipine in Hypertension

Hypertension Clinical Trial

Official title:
An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00614380
Other study ID # 1235.7
Secondary ID EUDRACT2007-0024
Status Completed
Phase Phase 3
First received January 28, 2008
Last updated December 16, 2013
Start date January 2008

Study information
Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health Canada (TPD)Denmark: Lægemiddelstyrelsen, Kliniske forsøg, Inspektionen Axel Heides Gade 1, DK-2300 Copenhagen SFinland: Finnish Medicines AgencyFrance: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTEKorea, Republic of: Korea Food and Drug Administration (KFDA)Netherlands: Central Committee on Research involving Human Subjects (CCMO)Norway: Norwegian Medicines Agency (Statens Legemiddelverk)Philippines: Department of Health, Republic of the PhilippinesSouth Africa: Medicines Control CouncilSweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products AgencyTaiwan: Department of Health, Executive Yuan, TaiwanUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

Recruitment information / eligibility
Status Completed
Enrollment 976
Est. completion date
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. patients aged at least 18 years

2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.

3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

Exclusion Criteria:

1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study

2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg

3. discontinuation from the preceding trial because of any adverse event or any other reason

4. known or suspected secondary hypertension

5. mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• telmisartan/amlodipine 40/5 mg fixed combination

• telmisartan/amlodipine 80/5 mg fixed combination

Locations
Country Name City State
Belgium 1235.7.32004 Boehringer Ingelheim Investigational Site Aywaille
Belgium 1235.7.32010 Boehringer Ingelheim Investigational Site Gozée
Belgium 1235.7.32008 Boehringer Ingelheim Investigational Site Linkebeek
Belgium 1235.7.32003 Boehringer Ingelheim Investigational Site Mol
Belgium 1235.7.32007 Boehringer Ingelheim Investigational Site Natoye
Belgium 1235.7.32002 Boehringer Ingelheim Investigational Site Tienen
Belgium 1235.7.32005 Boehringer Ingelheim Investigational Site Turnhout
Canada 1235.7.20007 Boehringer Ingelheim Investigational Site Bay Roberts Newfoundland and Labrador
Canada 1235.7.20001 Boehringer Ingelheim Investigational Site Coquitlam British Columbia
Canada 1235.7.20013 Boehringer Ingelheim Investigational Site Corunna Ontario
Canada 1235.7.20014 Boehringer Ingelheim Investigational Site Etobicoke Ontario
Canada 1235.7.20010 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1235.7.20012 Boehringer Ingelheim Investigational Site London Ontario
Canada 1235.7.20005 Boehringer Ingelheim Investigational Site Mount Pearl Newfoundland and Labrador
Canada 1235.7.20009 Boehringer Ingelheim Investigational Site Ottawa Ontario
Canada 1235.7.20003 Boehringer Ingelheim Investigational Site Sainte-Foy Quebec
Canada 1235.7.20006 Boehringer Ingelheim Investigational Site Sarnia Ontario
Canada 1235.7.20008 Boehringer Ingelheim Investigational Site St. John's Newfoundland and Labrador
Canada 1235.7.20011 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Denmark 1235.7.45002 Boehringer Ingelheim Investigational Site Birkerød
Denmark 1235.7.45005 Boehringer Ingelheim Investigational Site Haderslev
Denmark 1235.7.45008 Boehringer Ingelheim Investigational Site Herning
Denmark 1235.7.45009 Boehringer Ingelheim Investigational Site Hinnerup
Denmark 1235.7.45001 Boehringer Ingelheim Investigational Site Rødovre
Denmark 1235.7.45006 Boehringer Ingelheim Investigational Site Rødovre
Denmark 1235.7.45003 Boehringer Ingelheim Investigational Site Vaerløse
Denmark 1235.7.45007 Boehringer Ingelheim Investigational Site Vildbjerg
Finland 1235.7.35003 Boehringer Ingelheim Investigational Site Joensuu
Finland 1235.7.35004 Boehringer Ingelheim Investigational Site Joensuu
Finland 1235.7.35001 Boehringer Ingelheim Investigational Site Turku
Finland 1235.7.35002 Boehringer Ingelheim Investigational Site Turku
France 1235.7.3301H Boehringer Ingelheim Investigational Site Aigrefeuille S/Maine
France 1235.7.3306C Boehringer Ingelheim Investigational Site Angers
France 1235.7.3309B Boehringer Ingelheim Investigational Site Angers
France 1235.7.3309C Boehringer Ingelheim Investigational Site Angers
France 1235.7.3309E Boehringer Ingelheim Investigational Site Angers
France 1235.7.3309D Boehringer Ingelheim Investigational Site Avrille
France 1235.7.3309A Boehringer Ingelheim Investigational Site Beaucouze
France 1235.7.3305A Boehringer Ingelheim Investigational Site Bourg des cptes
France 1235.7.3306D Boehringer Ingelheim Investigational Site Briollay
France 1235.7.3308B Boehringer Ingelheim Investigational Site Cholet
France 1235.7.3308F Boehringer Ingelheim Investigational Site Cholet
France 1235.7.3302C Boehringer Ingelheim Investigational Site Garchizy
France 1235.7.3303C Boehringer Ingelheim Investigational Site Grandchamps
France 1235.7.3302D Boehringer Ingelheim Investigational Site Guerigny
France 1235.7.3310A Boehringer Ingelheim Investigational Site Jarny
France 1235.7.3301L Boehringer Ingelheim Investigational Site La Chapelle /s Erdre
France 1235.7.3301J Boehringer Ingelheim Investigational Site La Chapelle sur Erdre
France 1235.7.3304A Boehringer Ingelheim Investigational Site La Fresnais
France 1235.7.3308E Boehringer Ingelheim Investigational Site La Jubaudière
France 1235.7.3301G Boehringer Ingelheim Investigational Site La Montagne
France 1235.7.3307D Boehringer Ingelheim Investigational Site Le Mesnil en Vallée
France 1235.7.3301E Boehringer Ingelheim Investigational Site Le Temple de Bretagne
France 1235.7.3309F Boehringer Ingelheim Investigational Site Les Ponts de CE
France 1235.7.3305B Boehringer Ingelheim Investigational Site Louvigné le Bais
France 1235.7.3307E Boehringer Ingelheim Investigational Site Mouliherne
France 1235.7.3306A Boehringer Ingelheim Investigational Site Murs Erigne
France 1235.7.3307A Boehringer Ingelheim Investigational Site Murs-Erigne
France 1235.7.3301A Boehringer Ingelheim Investigational Site Nantes
France 1235.7.3301B Boehringer Ingelheim Investigational Site Nantes
France 1235.7.3301D Boehringer Ingelheim Investigational Site Nantes
France 1235.7.3301M Boehringer Ingelheim Investigational Site Nantes
France 1235.7.3302A Boehringer Ingelheim Investigational Site Nevers
France 1235.7.3302F Boehringer Ingelheim Investigational Site Nevers
France 1235.7.3301I Boehringer Ingelheim Investigational Site Nort sur Erdre
France 1235.7.3301C Boehringer Ingelheim Investigational Site Orvault
France 1235.7.3307F Boehringer Ingelheim Investigational Site Parcay les Pins
France 1235.7.3301N Boehringer Ingelheim Investigational Site Sautron
France 1235.7.3306B Boehringer Ingelheim Investigational Site Segre
France 1235.7.3301F Boehringer Ingelheim Investigational Site St Aubin les Châteaux
France 1235.7.3306F Boehringer Ingelheim Investigational Site St Georges de Montaigu
France 1235.7.3304B Boehringer Ingelheim Investigational Site St Ouen La Rouerie
France 1235.7.3306E Boehringer Ingelheim Investigational Site Thouars
France 1235.7.3304C Boehringer Ingelheim Investigational Site Tinténiac
France 1235.7.3308A Boehringer Ingelheim Investigational Site Vihiers
Korea, Republic of 1235.7.82007 Boehringer Ingelheim Investigational Site Busan
Korea, Republic of 1235.7.82001 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 1235.7.82006 Boehringer Ingelheim Investigational Site Daejon
Korea, Republic of 1235.7.82004 Boehringer Ingelheim Investigational Site Gangwon-Do
Korea, Republic of 1235.7.82008 Boehringer Ingelheim Investigational Site Gwangju
Korea, Republic of 1235.7.82002 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1235.7.82003 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1235.7.82005 Boehringer Ingelheim Investigational Site Seoul
Netherlands 1235.7.31008 Boehringer Ingelheim Investigational Site Beerzerveld
Netherlands 1235.7.31006 Boehringer Ingelheim Investigational Site Bennebroek
Netherlands 1235.7.31004 Boehringer Ingelheim Investigational Site Hoogwoud
Netherlands 1235.7.31003 Boehringer Ingelheim Investigational Site Musselkanaal
Netherlands 1235.7.31007 Boehringer Ingelheim Investigational Site Nijverdal
Netherlands 1235.7.31001 Boehringer Ingelheim Investigational Site Oude Pekela
Netherlands 1235.7.31005 Boehringer Ingelheim Investigational Site Roelofarendsveen
Netherlands 1235.7.31010 Boehringer Ingelheim Investigational Site Voerendaal
Norway 1235.7.47001 Boehringer Ingelheim Investigational Site Ålesund
Norway 1235.7.47002 Boehringer Ingelheim Investigational Site Bergen
Norway 1235.7.47003 Boehringer Ingelheim Investigational Site Hamar
Norway 1235.7.47004 Boehringer Ingelheim Investigational Site Oslo
Philippines 1235.7.63006 Boehringer Ingelheim Investigational Site Makati City
Philippines 1235.7.63001 Boehringer Ingelheim Investigational Site Manila
Philippines 1235.7.63002 Boehringer Ingelheim Investigational Site Manila
Philippines 1235.7.63009 Boehringer Ingelheim Investigational Site Manila
Philippines 1235.7.63008 Boehringer Ingelheim Investigational Site Pasay City
Philippines 1235.7.63005 Boehringer Ingelheim Investigational Site Pasig City
Philippines 1235.7.63003 Boehringer Ingelheim Investigational Site Quezon City
Philippines 1235.7.63007 Boehringer Ingelheim Investigational Site Quezon City
South Africa 1235.7.27003 Boehringer Ingelheim Investigational Site Boksburg
South Africa 1235.7.27006 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1235.7.27009 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1235.7.27010 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1235.7.27004 Boehringer Ingelheim Investigational Site Durban
South Africa 1235.7.27007 Boehringer Ingelheim Investigational Site Johannesburg
South Africa 1235.7.27008 Boehringer Ingelheim Investigational Site Johannesburg
South Africa 1235.7.27001 Boehringer Ingelheim Investigational Site Krugersdorp
South Africa 1235.7.27005 Boehringer Ingelheim Investigational Site Lenasia
South Africa 1235.7.27002 Boehringer Ingelheim Investigational Site Pretoria
Sweden 1235.7.46002 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1235.7.46003 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1235.7.46005 Boehringer Ingelheim Investigational Site Luleå
Sweden 1235.7.46004 Boehringer Ingelheim Investigational Site Rättvik
Sweden 1235.7.46001 Boehringer Ingelheim Investigational Site Stockholm
Taiwan 1235.7.88605 Boehringer Ingelheim Investigational Site Changhua
Taiwan 1235.7.88608 Boehringer Ingelheim Investigational Site Hualien City
Taiwan 1235.7.88601 Boehringer Ingelheim Investigational Site Kaohsiung
Taiwan 1235.7.88603 Boehringer Ingelheim Investigational Site Taichung

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  Finland,  France,  Korea, Republic of,  Netherlands,  Norway,  Philippines,  South Africa,  Sweden,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Trough Seated Diastolic Blood Pressure (DBP) Control The number of patients who reach the target DBP of <90mmHg End of study (34 weeks or last value on treatment) No
Secondary Trough Seated Systolic Blood Pressure (SBP) Control The number of patients who reach the target SBP of <140mmHg End of study (34 weeks or last value on treatment) No
Secondary Change From Baseline in Trough Seated Diastolic Blood Pressure Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5. End of study (34 weeks or last value on treatment) No
Secondary Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 The difference between the last available troughs represents the additional reduction in DBP in this study End of study (34 weeks or last value on treatment) No
Secondary Change From Baseline in Trough Seated Systolic Blood Pressure Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5. End of study (34 weeks or last value on treatment) No
Secondary Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 The difference between the last available troughs represents the additional reduction in SBP in this study End of study (34 weeks or last value on treatment) No
Secondary Trough Seated DBP Response The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg End of study (34 weeks or last value on treatment) No
Secondary Trough Seated SBP Response The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg End of study (34 weeks or last value on treatment) No
Secondary Trough Blood Pressure (BP) Normality Classes The number of patients who reach predefined BP categories End of study (34 weeks or last value on treatment) No
Secondary Time to First Additional Antihypertensive Time from first intake of medication to first intake of an antihypertensive other than the study drug At any point during open-label treatment No
Secondary Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment At any point during open-label treatment No
Secondary Additional Reduction in DBP by Use of Additional Antihypertensive Therapy Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7 At any point during open-label treatment No
Secondary Additional Reduction in SBP by Use of Additional Antihypertensive Therapy Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7 At any point during open-label treatment No
Secondary Trough DBP Control Pre- and Post- Uptitration The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration At any point during open-label treatment No
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