Overview

Irbesartan Versus Amlodipine: The OBI Study

Status:
Withdrawn
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
Summary
Objective: 1. To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects 2. To study the drug specific effect in arterial stiffness 3. To study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aristotle University Of Thessaloniki
Treatments:
Amlodipine
Hydrochlorothiazide
Irbesartan
Criteria
Inclusion Criteria:

1. Age between 18 and 60 years.

2. All patients are going to give their informed consent to participate in the study.

3. Stage I hypertension.

4. BMI > 30.

Exclusion Criteria:

1. Known oversensitiveness,

2. Chronic renal disease (GFR < 50 ml/min) or ESRD,

3. Heart or respiratory failure, OR

4. Recent MI, shock, liver deficiency (ALT or AST > 3 times normal and pregnancy or
lactation.