The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|