I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

NCT00362037 | Completed Phase 4

• 1 other identifier: PM_L_0255
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

Brief Summary

• To evaluate Blood Pressure (BP) reduction to the targeted values (BP ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients).
• To emphasize and to evaluate the benefit of Irbesartan in the reduction of left ventricular mass index in hypertensive patients with left ventricular hypertrophy.
• To demonstrate safety of Irbesartan in this population.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines

  During the study conduct

• Reduction in left ventricular hypertrophy from baseline values to week 36.

  during the study conduct

Secondary Outcomes (1)

• Occurrence of any side effect leading to treatment discontinuation.

  During all the study conduct

Interventions

Irbesartan (Aprovel) DRUG

Aprovel (150 \& 300mg) \& CoAprovel (300/12.5mg hydrochlorothiazide one per 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 proven mild to moderate Hypertension.
• 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.

You may not qualify if:

• Severe hypertension (Systolic BP ≥ 180 mm Hg or Diastolic BP ≥ 110 mm Hg).
• Patients with left ventricular ejection fraction \< 45%.
• Patients with severe left ventricular hypertrophy.
• Patients with known secondary hypertension (for another cause other than type 2 Diabetes Mellitus).
• Diabetic patients with HbA1c \> 10%.
• Significant chronic renal impairment (Serum creatinine \> 2.0 mg/dL).
• Significant liver disease as shown by SGPT/SGOT (ALT/AST) \> 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.

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: August 8, 2006
• First Posted: August 9, 2006
• Study Start: March 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 30, 2011

Record last verified: 2011-05

Locations

EG (1)