Irbesartan Versus Amlodipine: The OBI Study

Sponsor

Aristotle University Of Thessaloniki (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00987662

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective:

To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects
To study the drug specific effect in arterial stiffness
To study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)

Condition or Disease	Intervention/Treatment	Phase
Obesity Hypertension	Drug: Irbesartan Drug: Amlodipine	Phase 4

Detailed Description

Study Objectives

Primary:

Reduction of 24h BP in obese hypertensives
Reduction in arterial stiffness

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2013

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Irbesartan Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add HCZ 12.5 mg.	Drug: Irbesartan Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg.
Active Comparator: Amplodipine Treatment with amlodipine 10 mg for 4 weeks. If BP>135/85 mmHg add hydrochlorothiazide 12.5 mg	Drug: Amlodipine Treatment with amlodipine 10 mg for 4 weeks. If ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg

Arm

Intervention/Treatment

Active Comparator: Irbesartan

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

Drug: Irbesartan

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

Active Comparator: Amplodipine

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

Drug: Amlodipine

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

Outcome Measures

Primary Outcome Measures

Reduction of 24h BP and arterial stiffness in obese hypertensives [12]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 and 60 years.
All patients are going to give their informed consent to participate in the study.
Stage I hypertension.
BMI > 30.

Exclusion Criteria:

Known oversensitiveness,
Chronic renal disease (GFR < 50 ml/min) or ESRD,
Heart or respiratory failure, OR
Recent MI, shock, liver deficiency (ALT or AST > 3 times normal and pregnancy or lactation.