Irbesartan Versus Amlodipine: The OBI Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Aristotle University Of Thessaloniki.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Aristotle University Of Thessaloniki
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00987662
First received: September 30, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
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Purpose
Objective:
- To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects
- To study the drug specific effect in arterial stiffness
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (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
Primary:
- Reduction of 24h BP in obese hypertensives
- Reduction in arterial stiffness
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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987662
Contacts
| Contact: Vasilios Kotsis, Prof | +306974748860 | vkotsis@auth.gr |
Locations
| Greece | |
| Hypertension-24h ABPM Center Papageorgiou Hospital | Not yet recruiting |
| Thessaloniki, Greece | |
| Contact: Vasilios Kotsis, Prof | |
| Principal Investigator: Vasilios Kotsis, Prof | |
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: | September 30, 2009 |
| 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 May 19, 2013