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I PREVENT - Irbesartan In Hypertensive Diabetic Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00362258
First received: August 8, 2006
Last updated: April 1, 2011
Last verified: March 2011
History of Changes
  Purpose
  • 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 Intervention Phase
Hypertension
 Drug: Irbesartan (Aprovel)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Irbesartan In Hypertensive Diabetic Patients

Resource links provided by NLM:

Drug Information available for: Irbesartan
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]

Enrollment: 797
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Irbesartan (Aprovel)
    Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362258

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00362258     History of Changes
Other Study ID Numbers: PM_L_0256
Study First Received: August 8, 2006
Last Updated: April 1, 2011
Health Authority: Egypt: Ministry of Health and Population

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013