I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

NCT00335673 | Completed Phase 4

• 1 other identifier: IRBES_L_00165
• Study Type: interventional
• Target: 1,630
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study.

  During the study conduct

Secondary Outcomes (1)

• Occurrence of any side effects leading to treatment discontinuation.

  During the study conduct

Interventions

Irbesartan (Aprovel) DRUG

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Sanofi-Aventis Administrative Office

Cairo, Egypt

Location

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

• Mosaad I Morsi, MBBCh, MSc

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2006
• First Posted: June 12, 2006
• Study Start: February 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: April 1, 2011

Record last verified: 2011-03

Locations

EG (1)