Main
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Note: This record shows only 22 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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00549133 |
Date of registration:
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24/10/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
IREDIS |
Scientific title:
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Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol |
Date of first enrolment:
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October 2003 |
Target sample size:
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44 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00549133 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Edibe Taylan |
Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over
%6.5-8
- mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180
mmHg)
Exclusion Criteria:
- congestive heart failure
- azotemia
- insulin dependent diabetes
- liver insufficiency
- pregnancy
- cancer
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus Type 2
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Hypertension
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Intervention(s)
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Drug: Irbesartan
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Primary Outcome(s)
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Evaluation of the effect of irbesartan on nitric oxide (NO), which has key role in the endothelial dysfunction and the development of pressure vasomotor response, compared to standard therapy (atenolol)
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Secondary Outcome(s)
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Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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