| Trial ID: | L5122 |
| Source ID: | NCT00818779
|
| Associated Drug: |
Aliskiren
|
| Title: |
Direct Renin Inhibition Effects on Atherosclerotic Biomarkers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00818779/results
|
| Conditions: |
Coronary Artery Disease|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Aliskiren|DRUG: Amlodipine
|
| Outcome Measures: |
Primary: Plasminogen Activator Inhibitor 1, Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result., 6 weeks (change from baseline) | Secondary: Serum Level of Vascular Cell Adhesion Molecule, Surrogate biomarker cardiovascular risk, 6 week (change from baseline)|Serum Level of Intracellular Cell Adhesion Molecule, Surrogate biomarker of cardiovascular risk, 6 week (change from baseline)|Serum Level of C-reactive Protein, Surrogate biomarker of cardiovascular risk, 6 week (change from baseline)|Serum Level of Nitric Oxide, Surrogate biomarker of cardiovascular risk, 6 week (change from baseline)
|
| Sponsor/Collaborators: |
Sponsor: Texas Tech University Health Sciences Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2008-01
|
| Completion Date: |
2011-08
|
| Results First Posted: |
2012-11-19
|
| Last Update Posted: |
2017-12-05
|
| Locations: |
Texas Tech University Health Sciences Center, Lubbock, Texas, 79430, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00818779
|
