I PREVENT - Irbesartan In Hypertensive Diabetic Patients - Full Text View

Sponsor:	Sanofi-Aventis
Collaborator:	Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00362258

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Irbesartan In Hypertensive Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Irbesartan

Further study details as provided by Sanofi-Aventis:

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:	1081
Study Start Date:	February 2006
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.

Eligibility

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

Sponsors and Collaborators

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Study Director:

Mosaad I Morsi, MBBCh, MSc

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	PM_L_0256
Study First Received:	August 8, 2006
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00362258 History of Changes
Health Authority:	Egypt: Ministry of Health and Population

Additional relevant MeSH terms:

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

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010