Irbesartan Versus Amlodipine: The OBI Study (OBI)

February 10, 2014 updated by: Aristotle University Of Thessaloniki

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

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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Hypertension-24h ABPM Center Papageorgiou Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of 24h BP and arterial stiffness in obese hypertensives
Time Frame: 12
12

Secondary Outcome Measures

Outcome Measure
Time Frame
New onset of diabetes
Time Frame: 12
12
Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
Time Frame: 12
12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Study Chair: Vasilios Kotsis, Prof, AUTH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTH170909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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