Irbesartan Versus Amlodipine: The OBI Study

NCT00987662 | Withdrawn Phase 4 DMC

• 1 other identifier: AUTH170909
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objective:

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

Conditions

Obesity; Hypertension

Keywords

irbesartan; amlodipine; obesity; ambulatory blood pressure monitoring; new onset diabetes

Outcome Measures

Primary Outcomes (1)

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

  12

Secondary Outcomes (2)

• New onset of diabetes

  12

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

  12

Study Arms (2)

Irbesartan

ACTIVE COMPARATOR

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

Drug: Irbesartan

Amplodipine

ACTIVE COMPARATOR

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

Drug: Amlodipine

Interventions

Irbesartan DRUG

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

Irbesartan

Amlodipine DRUG

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

Amplodipine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Hypertension-24h ABPM Center Papageorgiou Hospital

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Obesity; Hypertension

Interventions

Irbesartan; Amlodipine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Dihydropyridines; Pyridines

Study Officials

• Vasilios Kotsis, Prof

  AUTH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 1, 2009
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 11, 2014

Record last verified: 2009-09

Locations

GR (1)