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OpenTrials
Completed

NCT Number: NCT00362037

I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

* 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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with proven mild to moderate Hypertension.
  • Patients must have left ventricular mass index > 130g/m2 in men, > 100g/m2 in women, as evidenced by echocardiography before inclusion.
  • 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 (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.

Treatment and study plan

Irbesartan (Aprovel)

Drug

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

Primary outcomes

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

    Time frame: During the study conduct

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

    Time frame: during the study conduct

Secondary outcomes

  1. Occurrence of any side effect leading to treatment discontinuation.

    Time frame: During all the study conduct

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 9, 2006
Registry last updated
May 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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