I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients - Full Text View

Sponsor:	Sanofi-Aventis
Collaborator:	Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00335673

Purpose

To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients.
To determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc…) at the end of the trial.

Condition	Intervention	Phase
Hypertension	Drug: Irbesartan (Aprovel)	Phase IV

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 Mild to Moderate Hypertensive Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Irbesartan

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of any side effects leading to treatment discontinuation. [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]

Enrollment:	1630
Study Start Date:	February 2006
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with proved mild to moderate hypertension.
Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension)OR
Patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion 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 (Systolic Blood Pressure ≥ 180 mm Hg or Diastolic Blood Pressure ≥ 110 mm Hg).
Patients with secondary hypertension (for another cause other than type 2 diabetes mellitus).
Patients with HbA1c > 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 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: NCT00335673

Locations

Egypt
Sanofi-Aventis Administrative Office
Cairo, Egypt

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:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00335673 History of Changes
Other Study ID Numbers:	IRBES_L_00165
Study First Received:	June 9, 2006
Last Updated:	March 31, 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 February 09, 2012