I PREVENT - Irbesartan In Hypertensive Diabetic Patients

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. Identifier: NCT00362258
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : April 4, 2011
Bristol-Myers Squibb
Information provided by:

Brief Summary:
  • To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.
  • To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population.
  • To demonstrate the safety of Irbesartan in this population.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan (Aprovel) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 797 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irbesartan In Hypertensive Diabetic Patients
Study Start Date : February 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Intervention Details:
  • Drug: Irbesartan (Aprovel)
    Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.

Primary Outcome Measures :
  1. Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg. [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min) [ Time Frame: During the study conduct ]
  2. First detection of overt nephropathy (UAE rate > 200µg / min), in patients with microalbuminuria or at least 30% higher than at baseline value(on at least two consecutive occasions) [ Time Frame: During the study conduct ]
  3. Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: During the study conduct ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Proven Hypertensive Type 2 Diabetic Patients with HbA1c > 6% and ≤ 10% (with or without microalbuminuria).
  • Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension). OR,
  • Patients who were receiving antihypertensive agents (maximum two agents, including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.

Exclusion Criteria:

  • Severe hypertension (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
  • Patients with secondary hypertension.
  • Patients with UAE > 200µg / min.
  • Patients with HbA1c < 6% or > 10%.
  • Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
  • Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) > 2.5 times the upper limit of the normal range.
  • Currently pregnant or lactating females.
  • Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
  • Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his/her physician).
  • Known hypersensitivity to irbesartan, other ARBs(Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
  • Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.

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

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 identifier (NCT number): NCT00362258

Sanofi-Aventis Administrative Office
Cairo, Egypt
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Mosaad I Morsi, MBBCh, MSc Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00362258     History of Changes
Other Study ID Numbers: PM_L_0256
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: April 4, 2011
Last Verified: March 2011

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