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Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria (PRIME)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00561964
First Posted: November 21, 2007
Last Update Posted: November 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Urine albumin excretion rate (UAER) [ Time Frame: during the study conduct ]

Secondary Outcome Measures:
  • SeSBP, SeDBP, Total cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol , glycated hemoglobin [ Time Frame: during the study conduct ]

Enrollment: 241
Study Start Date: January 2004
Study Completion Date: July 2005
Arms Assigned Interventions
Experimental: 1 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)
Placebo Comparator: 2 Drug: placebo
Placebo group: 2 placebo capsules daily as a single morning intake

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fasting plasma glucose of untreated type II diabetes mellitus patients greater than or equal to 7.0 mmol/L, or the time between diagnosis of type II diabetes mellitus and treatment > 3 months
  • The patients of normal BP, or hypertensive patients receiving antihypertensive medication, Seated systolic blood pressure (SeSBP) is between 120-180mmHg and the Seated diastolic blood pressure (SeDBP) is between 80-110mmHg;
  • Evidence of albuminuria defined as an AER of 20 and 500 ug/minute on a single timed overnight collection. Before randomization the patient must quality with two AERs of 3 days intervals in the absence of confounding factors such as urinary tract infection, acute febrile illness and cardiac failure. The two AERs measurement should be in the above defined range and the variability between the two AERs measurement must be <35%. Value of basal AER is calculated as the mean of the 2 measurements. The UAER measured using immunity nephelometer method (DCA2000);
  • Serum creatinine < 150umol/L(1.7mg/dl) and serum potassium in the normal lab range (3.5-5.5 mol/L);
  • 18 Kg/m2less than or equal to BMI less than or equal to 35Kg/m2

Exclusion Criteria:

  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
  Contacts and Locations
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): NCT00561964


Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Martin Thoenes Sanofi
  More Information

ClinicalTrials.gov Identifier: NCT00561964     History of Changes
Other Study ID Numbers: L_9079
First Submitted: November 20, 2007
First Posted: November 21, 2007
Last Update Posted: November 26, 2007
Last Verified: November 2007

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