Irbesartan Versus Amlodipine: The OBI Study

Phase 4

Withdrawn

• Conditions: Hypertension; Obesity
• Interventions: Drug: Irbesartan; Drug: Amlodipine

• Registration Number: NCT00987662
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief 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)

Detailed Description

Study Objectives

1. Primary:

* Reduction of 24h BP in obese hypertensives

* Reduction in arterial stiffness

2. Secondary

* Drug specific effect on new onset of diabetes

* Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio

Study design

Study drugs: Irbesartan 300mg vs. amlodipine 10mg

Tx duration and follow-up: 12 months

Collected data:

* 24h SBP and DBP in time 0, 1, 12.

* Pulse wave velocity in time 0,1,12.

* Central obesity (total, visceral, abdominal fat) in time 0,1,12.

* Leptin/adiponectin in time 0,1,12.

* BMI, waist/hip ratio in time 0,1, 12.

* Glu, HbA1c, insulin in time 0, 1,12.

* K, Na, Cr, BUN, Chol, Tg, HDL, LDL,ALT, AST in time 0, 1,12. Number of patients: The reduction in mean SBP expected to be 15 mmHg. Previous studies from our group reported an 14mmHg SD for mean SBP. The sample size required at the two sided 5% significance level and 80% power is 40 patients (Lehr's formula)

Number of centers: 1

Study Timeline

• Status Verified: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irbesartan	Irbesartan	Treatment with irbesartan 300mg for 4 weeks. IF ABP\>135/85 mmHg add HCZ 12.5 mg.
Amplodipine	Amlodipine	Treatment with amlodipine 10 mg for 4 weeks. If BP\>135/85 mmHg add hydrochlorothiazide 12.5 mg

Primary Outcome Measures

Name	Time	Method
Reduction of 24h BP and arterial stiffness in obese hypertensives	12

Secondary Outcome Measures

Name	Time	Method
New onset of diabetes	12
Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio	12

Trial Locations

Locations (1)

Hypertension-24h ABPM Center Papageorgiou Hospital; 🇬🇷 Thessaloniki, Greece