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Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00334581
First received: June 7, 2006
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

Primary objective:

  • To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria.

Secondary objectives:

  • To determine how well irbesartan 300mg is tolerated versus 150mg
  • To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg

Condition Intervention Phase
Hypertension
 Drug: Irbesartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria

Resource links provided by NLM:

Drug Information available for: Irbesartan
U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • The difference of urinary albumin excretion rate change [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reaching target BP of 130/80mmHg [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: May 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Irbesartan 150mg
 Drug: Irbesartan
Administration throughout the study period
Experimental: 2
Irbesartan 300mg
 Drug: Irbesartan
Administration throughout the study period

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min.
  • Blood pressure of < 180/110mmHg at baseline
  • Normal serum creatinine

Exclusion Criteria:

  • Type 1 diabetes
  • Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment
  • Pregnant or lactating women
  • Severe hypertension
  • Overt nephropathy
  • Allergy to study drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334581

Locations
China
Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Sanofi-Aventis
Bristol-Myers Squibb
Investigators
Study Director: Bruno Jolain Sanofi-Aventis
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00334581     History of Changes
Other Study ID Numbers: IRBES_L_00907
Study First Received: June 7, 2006
Last Updated: September 14, 2009
Health Authority: China: State Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2012