Irbesartan Versus Amlodipine: The OBI Study (OBI)
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|ClinicalTrials.gov Identifier: NCT00987662|
Recruitment Status : Withdrawn (no funding)
First Posted : October 1, 2009
Last Update Posted : February 11, 2014
- 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 or disease||Intervention/treatment||Phase|
|Obesity Hypertension||Drug: Irbesartan Drug: Amlodipine||Phase 4|
- Reduction of 24h BP in obese hypertensives
- Reduction in arterial stiffness
- Drug specific effect on new onset of diabetes
- Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
Study drugs: Irbesartan 300mg vs. amlodipine 10mg
Tx duration and follow-up: 12 months
- 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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2014|
Active Comparator: Irbesartan
Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add HCZ 12.5 mg.
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
Treatment with amlodipine 10 mg for 4 weeks. If ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg
- Reduction of 24h BP and arterial stiffness in obese hypertensives [ Time Frame: 12 ]
- New onset of diabetes [ Time Frame: 12 ]
- Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio [ Time Frame: 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987662
|Hypertension-24h ABPM Center Papageorgiou Hospital|
|Study Chair:||Vasilios Kotsis, Prof||AUTH|