HYZAAR vs. Ramipril for Diabetes (0954A-245)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Hypertension
Intervention: MK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks (Drug); Comparator : ramipril /Duration of Treatment : 8 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
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).
Clinical Details
Official title: HYZAAR Versus Ramipril Diabetic Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: To determine the antihypertensive effectiveness of HYZAAR as compared to Ramipril as measure by SiSBP at Week 4
Secondary outcome: To determine the safety anf tolerability of HYZAAR as compared to Ramipril as seen in overall adverse experiences for the duration of the study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: October 2002
Last updated: May 24, 2013
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