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A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus - NCT00660309-02115(Clinical Trial 215812)



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City:  Boston
State:  
MA
Zip Code: 02115
Conditions: Type 2 Diabetes Mellitus
Purpose: The study objective is to compare the effects of single and multiple doses of the oral direct renin inhibitor aliskiren and the angiotensin receptor antagonist irbesartan on renal blood flow, glomerular filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.
Study summary:
Criteria: Inclusion Criteria: - Patients must have been diagnosed with type 2 diabetes mellitus at least 6 months before the study, with history of hypertension or newly diagnosed hypertension. - Patients must be on a stable dose of hypoglycemic medications for at least 8 weeks prior to the study. - Patients must be medically able to discontinue anti- hypertensive medications for the duration of the study. - Female patients must be postmenopausal or surgically sterilized Exclusion Criteria: - Patients with Type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus. - Patients with glaucoma, or prior ocular surgery. - Patients with renal disease not caused by diabetes or hypertension. - Patients with heart failure or high serum potassium. - Patients with history of clinically significant drug or atopic allergy, acute or chronic respiratory disease, history of malignancy, or history of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any coronary intervention (PCI) during the 6 months prior to the study. - Any surgical or medical condition which may jeopardize the patient in case of participation in the study. - Participation in any clinical investigation within 4 weeks prior to the study. - Donation or loss of 400 mL or more of blood within 8 weeks prior to the study Other protocol-defined inclusion/exclusion criteria may apply.
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Data Source: ClinicalTrials.gov
Date Processed: April 13, 2010
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