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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00926289 |
The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff SBP compared to the monotherapy of T80 in patients with severe hypertension.
Condition | Intervention | Phase |
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Hypertension |
Drug: Telmisartan80mg Drug: Telmisartan80mg/hydrochlorothiazide25mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-blind, Controlled, Parallel Group Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/H25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3). |
Estimated Enrollment: | 840 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | June 2010 (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:
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00
a.m.
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 502.550, Eudra CT: 2008-007711-32 |
Study First Received: | June 22, 2009 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00926289 History of Changes |
Health Authority: | Bulgaria: Bulgarian Drug Agency; China: State Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Georgia: Ministry of Health; Korea: Food and Drug Administration; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; United States: Food and Drug Administration |
Anti-Infective Agents Benzoates Diuretics Sodium Chloride Symporter Inhibitors Vascular Diseases Cardiovascular Agents Antihypertensive Agents Angiotensin II |
Hydrochlorothiazide Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Antifungal Agents Angiotensin-Converting Enzyme Inhibitors Telmisartan Hypertension |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Benzoates Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide |
Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Antifungal Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |