HYZAAR vs. Ramipril for Diabetes - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00480805

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	HYZAAR Versus Ramipril Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Hydrochlorothiazide Ramipril Losartan Losartan potassium Hyzaar

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.

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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Ramipril
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents
Losartan
Metabolic Diseases
Vascular Diseases

Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Natriuretic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009