Comparison of Eprosartan/HCT Versus Enalapril/HCT in Hypertensives With Type II Diabetes

This study has been completed.

First Received on September 8, 2005. Last Updated on January 29, 2009 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160160

Purpose

This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ.

Condition	Intervention
Hypertension Type 2 Diabetes	Drug: eprosartan/HCTZ

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-Center, Double-Blind, Randomized Study Comparing the Efficacy of Combination Therapy of Eprosartan Respectively Ramipril With Low-Dose Hydrochlorothiazide and Moxonidine on Blood Pressure Levels in Patients With Hypertension and Associated Diabetes Mellitus Type 2

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 High Blood Pressure

Drug Information available for: Eprosartan Eprosartan mesylate

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Blood pressure reduction

Secondary Outcome Measures:

Comparison of responder rates

Estimated Enrollment:	440
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

essential hypertension,
diabetes type 2

Exclusion Criteria:

severe cardiovascular disease,
grade 3 hypertension,
secondary hypertension,
abnormal liver enzymes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160160

Show 63 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00160160 History of Changes
Other Study ID Numbers:	S171.3.012, 2004-00703-18
Study First Received:	September 8, 2005
Last Updated:	January 29, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Solvay Pharmaceuticals:

comparator trial
hypertension
diabetes
blood pressure

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

Eprosartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 2 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012