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

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.

Sponsors and Collaborators:	Sanofi-Aventis 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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Irbesartan

U.S. FDA Resources

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

Further study details as provided by Sanofi-Aventis:

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
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561964

Sponsors and Collaborators

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Study Director:

Martin Thoenes

Sanofi-Aventis

More Information

Posting of clinical results This link exits the ClinicalTrials.gov site

Study ID Numbers:	L_9079
Study First Received:	November 20, 2007
Last Updated:	November 22, 2007
ClinicalTrials.gov Identifier:	NCT00561964
Health Authority:	China: SFDA CDE

Study placed in the following topic categories:

Irbesartan
Vascular Diseases
Angiotensin II
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009