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Clinical Trial Details

Trial ID: L4896
Source ID: NCT01409408
Associated Drug: Aliskiren
Title: Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Hypertension|Diabetes Mellitus
Interventions: DRUG: Aliskiren|DRUG: Amlodipine
Outcome Measures: Primary: Vascular stiffness, Vascular stiffness will be measured by pulse wave velocity and augmentation index and compared between anlodipine and aliskiren., 8 weeks|Endothelial function, Access endothelial function by peripheral arterial tonometry and brachial flow-mediated vasodilation and compare it between anlodipine and aliskiren., 8 weeks|Renin activity and concentration, Access plasma renin activity and concentration and compare it between anlodipine and aliskiren., 8 weeks | Secondary: Compare drug effects in office blood pressure measurements to those obtained by home blood pressure monitoring and ambulatory blood pressure monitoring, Compare drug effects in office blood pressure measurements to those obtained by home blood pressure monitoring and ambulatory blood pressure monitoring, 8 weeks|Assess drugs effects in renin-angiotensin-aldosterone system (RAAS) and correlate it to renin concentration/mass and plasmatic renin activity, Assess drugs effects in RAAS and correlate it to renin concentration/mass and plasmatic renin activity, 8 weeks|Correlation of drug effects and uric acid plasmatic concentration, Correlation of drug effects and uric acid plasmatic concentration, 8 weeks|Correlation of drug effects and glomerular filtration rate, Correlation of drug effects and glomerular filtration rate, 8 weeks|Correlation of drug effects and microalbuminuria, Correlation of drug effects and microalbuminuria, 8 weeks|Correlation of drug effects and left ventricular mass and function (systolic and diastolic), Correlation of drug effects and left ventricular mass and function (systolic and diastolic), 8 weeks
Sponsor/Collaborators: Sponsor: Hospital Universitario Pedro Ernesto | Collaborators: Novartis
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2011-04
Completion Date: 2013-12
Results First Posted:
Last Update Posted: 2012-03-06
Locations: Hospital Universitario Pedro Ernesto, Rio de Janeiro, 20551030, Brazil
URL: https://clinicaltrials.gov/show/NCT01409408