Back to resultsHYZAAR vs. Ramipril for Diabetes (0954A-245)(COMPLETED)
Primary Purpose
Type 2 Diabetes Mellitus, Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks
Comparator : ramipril /Duration of Treatment : 8 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
To determine the antihypertensive effectiveness of HYZAAR as compared to Ramipril as measure by SiSBP at Week 4
Secondary Outcome 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00480805
Brief Title
HYZAAR vs. Ramipril for Diabetes (0954A-245)(COMPLETED)
Official Title
HYZAAR Versus Ramipril Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 8, 2001 (Actual)
Primary Completion Date
October 15, 2002 (Actual)
Study Completion Date
October 16, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator : ramipril /Duration of Treatment : 8 Weeks
Primary Outcome Measure Information:
Title
To determine the antihypertensive effectiveness of HYZAAR as compared to Ramipril as measure by SiSBP at Week 4
Secondary Outcome Measure Information:
Title
To determine the safety anf tolerability of HYZAAR as compared to Ramipril as seen in overall adverse experiences for the duration of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15308882
Citation
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. doi: 10.1111/j.1524-6175.2004.03488.x.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
HYZAAR vs. Ramipril for Diabetes (0954A-245)(COMPLETED)
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