Phase 4
Completed N=38
Direct Renin Inhibition Effects on Atherosclerotic Biomarkers
Source: ClinicalTrials.gov NCT00818779 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Plasminogen Activator Inhibitor 1 — 0.65; 3.82 ng/ml
Summary
The investigators aim to assess if a new blood pressure medication, aliskiren, reduces various biomarkers of heart disease found in the blood in patients with a history of both heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these biomarkers compared to a calcium channel blocker.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasminogen Activator Inhibitor 1 |
0.65; 3.82 | — |
| SECONDARY Serum Level of Vascular Cell Adhesion Molecule |
-2.4; -45.9 | — |
| SECONDARY Serum Level of Intracellular Cell Adhesion Molecule |
-4.9; -10.3 | — |
| SECONDARY Serum Level of C-reactive Protein |
0.0397; 0.1032 | — |
| SECONDARY Serum Level of Nitric Oxide |
2.66; 7.49 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 2 diabetes
- Diagnosis of coronary artery disease
- Currently receiving therapy with an ACE-Inhibitor or Angiotensin Receptor Blocker
- Currently receiving antiplatelet therapy and statin therapy
- Baseline blood pressure > 100/75 mm Hg
- BMI 25-35 kg/m2
Exclusion Criteria
- Concurrent calcium channel blocker therapy
- Documented peripheral edema
- Hyperkalemia
- Serum creatinine > 2.0
- Diagnosed with proteinuria
- Diagnosed with liver dysfunction or serious rheumatological disorder
Data sourced from ClinicalTrials.gov (NCT00818779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.