| Trial ID: | L7252 |
| Source ID: | NCT00994253
|
| Associated Drug: |
Aliskiren
|
| Title: |
Evaluating the Effect of Aliskiren Versus HCTZ on Coronary Flow Reserve in Hypertensive Type II Diabetics
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Diabetes Type 2
|
| Interventions: |
DRUG: Aliskiren|DRUG: Hydrochlorothiazide
|
| Outcome Measures: |
Primary: The primary objective is to assess the effect of a multimodal drug therapy regimen including the renin inhibitor Tekturna (aliskiren), an ACE inhibitor, and a calcium channel blocker on coronary flow reserve (CFR) in hypertensive Type II diabetics., CFR will be assessed by a PET-based imaging technique., 6 months | Secondary: Secondary measures include evaluation of serum and urine biomarkers related to endothelial function, the renin-angiotensin system, oxidative stress, and inflammation., Biomarkers include asymmetric dimethylarginine, B-type natriuretic peptide, plasma renin activity, high-sensitivity C-reactive protein, adiponectin, aldosterone, angiotensinogen, and hemoglobin A1c., 6 months
|
| Sponsor/Collaborators: |
Sponsor: William Beaumont Hospitals | Collaborators: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-08
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-10-02
|
| Locations: |
William Beaumont Hospital, Royal Oak, Michigan, 48073, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00994253
|
