- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00334581
Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria
September 14, 2009 updated by: Sanofi
A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Irbesartan 150mg
|
Administration throughout the study period
|
Experimental: 2
Irbesartan 300mg
|
Administration throughout the study period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference of urinary albumin excretion rate change
Time Frame: at week 24
|
at week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients reaching target BP of 130/80mmHg
Time Frame: At week 24
|
At week 24
|
Adverse events
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Bruno Jolain, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
June 7, 2006
First Submitted That Met QC Criteria
June 7, 2006
First Posted (Estimate)
June 8, 2006
Study Record Updates
Last Update Posted (Estimate)
September 15, 2009
Last Update Submitted That Met QC Criteria
September 14, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBES_L_00907
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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