Irbesartan Versus Amlodipine: The OBI Study

Obesity Clinical Trial

— OBI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00987662
• Other study ID #: AUTH170909
• Status: Withdrawn
• Phase: Phase 4
• First received: September 30, 2009
• Last updated: February 10, 2014
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2009
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension
• Obesity

Intervention

Drug:
• Irbesartan
Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg.
• Amlodipine
Treatment with amlodipine 10 mg for 4 weeks. If ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg

Locations

Country	Name	City	State
Greece	Hypertension-24h ABPM Center Papageorgiou Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of 24h BP and arterial stiffness in obese hypertensives		12	No
Secondary	New onset of diabetes		12	No
Secondary	Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio		12	No