The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis
|ClinicalTrials.gov Identifier: NCT01067326|
Recruitment Status : Terminated (Novartis ended all studies regarding Aliskiren.)
First Posted : February 11, 2010
Results First Posted : February 13, 2013
Last Update Posted : February 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Endothelial Dysfunction||Drug: Aliskiren Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Aliskiren
150 mg Aliskiren once daily for a period of 4 months.
150 mg Aliskiren once daily for a period of 4 months
Placebo Comparator: Placebo
1 pill per day by mouth for 4 months.
1 pill per day by mouth for 4 months
- Endothelial Progenitor Cells (EPC) [ Time Frame: Baseline, 4 Months ]Peripheral blood mononuclear cells were stained for EPC markers (cell-surface antigens CD34/CD133/KDR) and counted by flow-cytometry.
- Reactive Hyperemia Index (RHI) [ Time Frame: Baseline, 4 Months ]RHI was measured by the noninvasive endothelial peripheral arterial tomography (EndoPat) test. EndoPAT results are reported as the "Endoscore" (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart.
- Systolic Blood Pressure [ Time Frame: Baseline, 4 Months ]
- Diastolic Blood Pressure [ Time Frame: Baseline, 4 Months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067326
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amir Lerman, MD||Mayo Clinic|