HYZAAR vs. Ramipril for Diabetes

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00480805

First received: May 30, 2007

Last updated: June 5, 2007

Last verified: June 2007

History of Changes

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:

MedlinePlus related topics: Diabetes Diabetes Type 2 High Blood Pressure Potassium

Drug Information available for: Hydrochlorothiazide Ramipril Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

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

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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.

ClinicalTrials.gov Identifier:	NCT00480805 History of Changes
Other Study ID Numbers:	2007_554
Study First Received:	May 30, 2007
Last Updated:	June 5, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Ramipril
Losartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
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 May 19, 2013

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