Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00624052 |
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations T40/A10 or T80/A10 during open-label treatment for at least six months. An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.
The primary endpoint is the proportion of patients achieving diastolic blood pressure (DBP) control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Official Title: | An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension |
Enrollment: | 838 |
Study Start Date: | March 2008 |
Primary Completion Date: | June 2009 (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:
diagnosis of essential hypertension
Exclusion Criteria:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1235.8, EUDRACT 2007-002422-29 |
Study First Received: | February 5, 2008 |
Last Updated: | July 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00624052 History of Changes |
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 prov. 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 (AEMPS); Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) |
Anti-Infective Agents Vasodilator Agents Benzoates Vascular Diseases Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents Angiotensin II |
Protease Inhibitors Amlodipine Angiotensin II Type 1 Receptor Blockers Calcium, Dietary Antifungal Agents Angiotensin-Converting Enzyme Inhibitors Telmisartan Hypertension |
Anti-Infective Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Benzoates Vascular Diseases Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Amlodipine Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Antifungal Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |