HYZAAR vs. Ramipril for Diabetes (0954A-245)(COMPLETED)

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; Hypertension

• Registration Number: NCT00480805
• Lead Sponsor: Organon and Co

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08-08
• Primary Completion: 2002-10-15
• Study Completion: 2002-10-16
• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the antihypertensive effectiveness of HYZAAR as compared to Ramipril as measure by SiSBP at Week 4

Secondary Outcome Measures

Name	Time	Method
To determine the safety anf tolerability of HYZAAR as compared to Ramipril as seen in overall adverse experiences for the duration of the study