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Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

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ClinicalTrials.gov Identifier: NCT00334581
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : September 15, 2009
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi

Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria
Study Start Date : May 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arm Intervention/treatment
Experimental: 1
Irbesartan 150mg
Drug: Irbesartan
Administration throughout the study period

Experimental: 2
Irbesartan 300mg
Drug: Irbesartan
Administration throughout the study period




Primary Outcome Measures :
  1. The difference of urinary albumin excretion rate change [ Time Frame: at week 24 ]

Secondary Outcome Measures :
  1. Percentage of patients reaching target BP of 130/80mmHg [ Time Frame: At week 24 ]
  2. Adverse events [ Time Frame: From the beginning to the end of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334581


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

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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00334581     History of Changes
Other Study ID Numbers: IRBES_L_00907
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
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Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action