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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00987662 |
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Date of registration:
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30/09/2009 |
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Primary sponsor: |
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Public title:
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Irbesartan Versus Amlodipine: The OBI Study
OBI |
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Scientific title:
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Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00987662 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Greece
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Contacts
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Name:
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Vasilios Kotsis, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Vasilios Kotsis, Prof |
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Address:
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Telephone:
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+306974748860 |
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Email:
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vkotsis@auth.gr |
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Affiliation:
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Name:
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Vasilios Kotsis, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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AUTH |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Obesity
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Intervention(s)
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Drug: Amlodipine
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Drug: Irbesartan
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Primary Outcome(s)
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Reduction of 24h BP and arterial stiffness in obese hypertensives
[Time Frame: 12]
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Secondary Outcome(s)
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Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
[Time Frame: 12]
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New onset of diabetes
[Time Frame: 12]
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Secondary ID(s)
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AUTH170909
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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