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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00553267 |
Purpose
The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: fixed dose combination of telmisartan+amlodipine Drug: amlodipine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy |
| Enrollment: | 947 |
| Study Start Date: | November 2007 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 97 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00553267 History of Changes |
| Other Study ID Numbers: | 1235.6, EUDRACT 2007-002421-68 |
| Study First Received: | October 8, 2007 |
| Results First Received: | November 18, 2009 |
| Last Updated: | January 20, 2010 |
| Health Authority: | Australia: Responsilble Ethics Committee; Austria: Federal Office for Safety in Health Care; Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Great Britain: MHRA; Ireland: Irish Medicines Board; Italy: Comitato Etico della provinciale di Ferrara; New Zealand: Multicentre Ethics Committee/Medsafe; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Spain: Agencia Española del Medicamento y Productos Sanitarios; Switzerland: Swissmedic, Hallerstrasse 7, 3000 Bern; Turkey: Ministry of Health Central Ethics Committee; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) |
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Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Telmisartan Benzoates Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents |
Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |