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

NCT00561964 | Completed Phase 3

• 1 other identifier: L_9079
• Study Type: interventional
• Target: 241
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Urine albumin excretion rate (UAER)

  during the study conduct

Secondary Outcomes (1)

• SeSBP, SeDBP, Total cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol , glycated hemoglobin

  during the study conduct

Study Arms (2)

1

EXPERIMENTAL

Drug: Irbesartan

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Irbesartan DRUG

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)

1

placebo DRUG

Placebo group: 2 placebo capsules daily as a single morning intake

2

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Kg/m2less than or equal to BMI less than or equal to 35Kg/m2

You may not qualify if:

• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead
• Bristol-Myers Squibb: collaborator

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Martin Thoenes

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: January 1, 2004
• Study Completion: July 1, 2005
• Last Updated: November 26, 2007

Record last verified: 2007-11