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

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

Date First Received: September 8, 2005

Last Updated: January 29, 2009

Verified by: Solvay Pharmaceuticals, January 2009

Clinical Trial Phase: N/A | Start Date: October 2004

Overall Status: Completed

Estimated Enrollment: 440

Brief Summary

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”

Condition Keyword(s):

Intervention(s):

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: eprosartan/HCTZ

Outcome Measures for this Clinical Trial

Primary Measures

  • Blood pressure reduction

Secondary Measures

  • Comparison of responder rates

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • essential hypertension,
  • diabetes type 2

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160160

Study ID Number: S171.3.012

ClinicalTrials.gov Identifier: NCT00160160

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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