Irbesartan Versus Amlodipine: The OBI Study

This study has been withdrawn prior to enrollment.
(no funding)
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00987662
First received: September 30, 2009
Last updated: February 10, 2014
Last verified: September 2009
  Purpose

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)

Condition Intervention Phase
Obesity
Hypertension
Drug: Irbesartan
Drug: Amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Reduction of 24h BP and arterial stiffness in obese hypertensives [ Time Frame: 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • New onset of diabetes [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio [ Time Frame: 12 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987662

Locations
Greece
Hypertension-24h ABPM Center Papageorgiou Hospital
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Chair: Vasilios Kotsis, Prof AUTH
  More Information

No publications provided

Responsible Party: Kotsis Vasilios/Prof, Papageorgiou hospital hypertension/24h ABPM center
ClinicalTrials.gov Identifier: NCT00987662     History of Changes
Other Study ID Numbers: AUTH170909
Study First Received: September 30, 2009
Last Updated: February 10, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
irbesartan
amlodipine
obesity
ambulatory blood pressure monitoring
new onset diabetes

Additional relevant MeSH terms:
Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hydrochlorothiazide
Irbesartan
Amlodipine
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 29, 2014