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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00561964 |
Purpose
To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Irbesartan Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria |
| Enrollment: | 241 |
| Study Start Date: | January 2004 |
| Study Completion Date: | July 2005 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Irbesartan
Irbesartan capsules strength 150 mg. Irbesartan group will be initiated at one irbesartan and one placebo for 2 weeks and titrated at two capsules if well tolerated after 2 weeks , this dose will be maintained throughout the study without further dose-adjustment (2 capsules daily in the morning will be taken from randomization to study end)
|
| 2: Placebo Comparator |
Drug: placebo
Placebo group: 2 placebo capsules daily as a single morning intake
|
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | L_9079 |
| Study First Received: | November 20, 2007 |
| Last Updated: | November 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00561964 History of Changes |
| Health Authority: | China: SFDA CDE |
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Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Irbesartan Vascular Diseases |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Hypertension |