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Study 9 of 427 for search of: | Canada, Newfoundland and Labrador |
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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00558428 |
The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.
Condition | Intervention | Phase |
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Hypertension |
Drug: fixed dose combination of telmisartan+amlodipine Drug: amlodipine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Eight-Week Randomized, 4-Arm, Double-Blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy |
Enrollment: | 1098 |
Study Start Date: | October 2007 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1235.5, EUDRACT2007-002409-36 |
Study First Received: | October 29, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00558428 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; Denmark: Ethics Committee; France: Afssaps - French Health Products Safety Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency; Taiwan: Department of Health; South Korea: Korea Food and Drug Administration (KFDA); Philippines: Department of Health; Finland: Ethics Committee; Sweden: Regional Ethical Review Board; South Africa: Medicines Control Council; United States: Food and Drug Administration |
Calcium, Dietary Vascular Diseases Telmisartan |
Angiotensin II Amlodipine Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Membrane Transport Modulators Angiotensin II Type 1 Receptor Blockers Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |