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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00480805
First received: May 30, 2007
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Hypertension
Drug: MK0954A, losartan potassium (+) hydrochlorothiazide (HYZAAR) / Duration of Treatment : 8 Weeks
Drug: Comparator : ramipril /Duration of Treatment : 8 Weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: HYZAAR Versus Ramipril Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Estimated Enrollment: 280
Study Start Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480805

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00480805     History of Changes
Other Study ID Numbers: 2007_554
Study First Received: May 30, 2007
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydrochlorothiazide
Ramipril
Losartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on October 01, 2014