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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00546754 |
Purpose
To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: losartan potassium (+) hydrochlorothiazide Drug: Comparator: Valsartan (+) Hydrochlorothiazide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | BP-EASE-A 12-Week, Multicenter, Open-Label, Randomized, Controlled Trial To Compare The Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Titrated as Needed to Losartan 100 mg/HCTZ 25 mg or Valsartan 160 mg/HCTZ 25 mg, in Patients With Essential Hypertension Who Have Not Achieved Target Blood Pressure With |
| Enrollment: | 808 |
| Study Start Date: | May 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Drug Arm
|
Drug: losartan potassium (+) hydrochlorothiazide
losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide
|
|
Active Comparator: 2
active comparator
|
Drug: Comparator: Valsartan (+) Hydrochlorothiazide
Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00546754 History of Changes |
| Other Study ID Numbers: | 2007_031, MK0954A-333 |
| Study First Received: | October 17, 2007 |
| Results First Received: | March 26, 2010 |
| Last Updated: | April 20, 2010 |
| Health Authority: | Canada: Health Canada |
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Valsartan Losartan 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 Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |