A study to test the safety and efficacy of HYZAAR as compared to Ramipril in patients with type 2 diabetes mellitus (high blood sugar) and hypertension (high blood pressure)...
Date First Received: May 30, 2007
Last Updated: June 5, 2007
Verified by: Merck, June 2007
Clinical Trial Phase: Phase 3 | Start Date: October 2002
Overall Status: Completed
Estimated Enrollment: 280
Brief Summary
Official Title: “HYZAAR Versus Ramipril Diabetic Patients”
Condition Keyword(s):
A study to test the safety and efficacy of HYZAAR as compared to Ramipril in patients with type 2 diabetes mellitus (high blood sugar) and hypertension (high blood pressure).
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks
- Drug: Comparator : ramipril /Duration of Treatment : 8 Weeks
Outcome Measures for this Clinical Trial
Primary Measures
- To determine the antihypertensive effectiveness of HYZAAR as compared to Ramipril as measure by SiSBP at Week 4
Secondary Measures
- To determine the safety anf tolerability of HYZAAR as compared to Ramipril as seen in overall adverse experiences for the duration of the study
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patient is at least 18 years old, has been diagnosed with type 2 diabetes mellitus
Exclusion Criteria:
- Patient has renal disease, malignant hypertension, uncontrolled type 2 diabetes mellitus, history of stroke, TIA (Transient Ischemic Attacks) , or heart disease
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Fox JC, Leight K, Sutradhar SC, Demopoulos LA, Gleim GW, Lewin AJ, Bakris GL. The JNC 7 approach compared to conventional treatment in diabetic patients with hypertension: a double-blind trial of initial monotherapy vs. combination therapy. J Clin Hypertens (Greenwich). 2004 Aug;6(8):437-42; quiz 443-4.
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00480805
Study ID Number: 2007_554
ClinicalTrials.gov Identifier: NCT00480805
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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