Irbesartan Versus Amlodipine: The OBI Study

NCT ID: NCT00987662

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

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

Conditions

Obesity; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Irbesartan

Treatment with irbesartan 300mg for 4 weeks. IF ABP\>135/85 mmHg add HCZ 12.5 mg.

Group Type: ACTIVE_COMPARATOR

Irbesartan

Intervention Type: DRUG

Treatment with irbesartan 300mg for 4 weeks. IF ABP\>135/85 mmHg add hydrochlorothiazide 12.5 mg.

Amplodipine

Treatment with amlodipine 10 mg for 4 weeks. If BP\>135/85 mmHg add hydrochlorothiazide 12.5 mg

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

Treatment with amlodipine 10 mg for 4 weeks. If ABP\>135/85 mmHg add hydrochlorothiazide 12.5 mg

Interventions

Irbesartan

Treatment with irbesartan 300mg for 4 weeks. IF ABP\>135/85 mmHg add hydrochlorothiazide 12.5 mg.

Intervention Type: DRUG

Amlodipine

Treatment with amlodipine 10 mg for 4 weeks. If ABP\>135/85 mmHg add hydrochlorothiazide 12.5 mg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Papageorgiou hospital hypertension/24h ABPM center

Principal Investigators

Vasilios Kotsis, Prof

Role: STUDY_CHAIR

AUTH

Locations

Hypertension-24h ABPM Center Papageorgiou Hospital

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

AUTH170909

Identifier Type: -

Identifier Source: org_study_id