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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00240448 |
Purpose
The primary objective of this study is to compare the effectiveness of telmisartan 80 mg/hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg/hydrochlorothiazide 25 mg [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: telmisartan 80 mg/hydrochlorothiazide 25 mg Drug: valsartan 160 mg/hydrochlorothiazide 25 mg Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Double-dummy, Placebo-controlled, Forced-titration, Comparison of Micardis HCT (Telmisartan 80 mg / Hydrochlorothiazide 25 mg) Versus Diovan HCT (Valsartan 160 mg / Hydrochlorothiazide 25 mg) Using Seated Trough Cuff Blood Pressure in Patients With Stage 1 and Stage 2 Hyp |
| Estimated Enrollment: | 1035 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | December 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Contacts and Locations
Show 100 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| ClinicalTrials.gov Identifier: | NCT00240448 History of Changes |
| Other Study ID Numbers: | 502.421 |
| Study First Received: | October 14, 2005 |
| Last Updated: | September 27, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Valsartan Telmisartan Telmisartan, hydrochlorothiazide drug combination Benzoates Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |