APROVE : Irbesartan in Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00283036
• Date of registration: 26/01/2006
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: APROVE : Irbesartan in Hypertension
• Scientific title: Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients
• Date of first enrolment: April 2005
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00283036
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Algeria

Contacts

• Name: Nabil BENOUNICHE, MD
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient with mild or moderate hypertension defined with arterial diastolic pressure
(PAD) at sit position between 90 mmHg and 110 mmHg and arterial systolic pressure
(PAS) at sit position between 140 mmHg and 180 mmHg.

- Patient diagnosed after 3 consultations within 2 months who has never been under
treatment and responding to the required conditions for hypertension treatment with
irbesartan. This patient must has been under proper but insufficient hygieno dietetic
diet

- Patient who has been under a none satisfied antihypertensive treatment, and for whom
this treatment was stopped at least 2 weeks prior to inclusion.

- Patient with a laboratory analysis (urinary sediment- Na -K- creatinine, total
cholesterol) and ECG during the month prior to inclusion.

Exclusion Criteria:

- Severe Hypertension defined by PAS > 180mmHg and/or PAD > 110 mmHg.

- Isolated systolic Hypertension

- Secondary Hypertension

- Arterial stenosis on unique kidney - arterial bilateral kidney stenosis

- Non-surgically sterilized women or non-menopaused women.

- Confirmed sodic depletion.

- Hypersensitivity to Irbesartan.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Irbesartan

Primary Outcome(s)

Tolerability

Arterial Tension

Secondary ID(s)

L_8793

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb