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WithdrawnNCT00987662OBIUpdated Feb 11, 2014

Irbesartan Versus Amlodipine: The OBI Study

A Phase 4 interventional study of Irbesartan and Amlodipine in Obesity and Hypertension, sponsored by Aristotle University Of Thessaloniki. Withdrawn at 1 site in Greece. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-02-11.

Sponsored by Aristotle University Of Thessaloniki · Phase 4, Interventional, and Diagnostic

Why this study was withdrawn
no funding
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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)
Read the 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

02

Conditions studied

  • Obesity
  • Hypertension

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Keywords

  • irbesartan
  • amlodipine
  • obesity
  • ambulatory blood pressure monitoring
  • new onset diabetes
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

Browse Obesity studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Irbesartan

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

    Drug: Irbesartan

  • Active comparator
    Amplodipine

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

    Drug: Amlodipine

Interventions

  • DrugIrbesartan

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

  • DrugAmlodipine

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

06

What researchers measure

Primary outcomes

  1. Reduction of 24h BP and arterial stiffness in obese hypertensives

    Time frame: 12

Secondary outcomes

  1. New onset of diabetes

    Time frame: 12

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

    Time frame: 12

07

Study locations

1 site
  • Hypertension-24h ABPM Center Papageorgiou Hospital
    Thessaloniki, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00987662
Lead sponsor
Aristotle University Of Thessaloniki
First posted
Oct 1, 2009
Start date
Jan 2012
Primary completion
Jan 2013 (estimated)
Completion
Jan 2014 (estimated)
Last update
Feb 11, 2014

Study contacts

Vasilios Kotsis, Prof
study chair · AUTH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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