Last reviewed · How we verify
NCT00818779
Effects of Direct Renin Inhibition on Atherosclerotic Biomarkers in Patients With Stable Coronary Heart Disease and Type 2 Diabetes Mellitus
Phase 4 trial testing Aliskiren in Coronary Artery Disease in 38 participants. Completed in 1 August 2011.
1 August 2011
Quick facts
| Lead sponsor | Texas Tech University Health Sciences Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 38 |
| Start date | 1 January 2008 |
| Primary completion | 1 August 2011 |
| Estimated completion | 1 August 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aliskiren (ALISKIREN) — full drug profile →
- Amlodipine (amlodipine) — full drug profile →
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Texas Tech University Health Sciences Center
Who can join
Adults 18 to 85, any sex, with Coronary Artery Disease or Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Plasminogen Activator Inhibitor 1
Time frame: 6 weeks (change from baseline)
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00818779
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aliskiren
Trials testing the same drug.
- NCT06718062 — Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia · Phase 4 · completed
- NCT00667719 — A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Ess · Phase 3 · completed
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
- NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
- NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
- NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Other Texas Tech University Health Sciences Center trials
Trials by the same sponsor.
- NCT07348406 — Snacks and Brain Health · Phase 1, PHASE2 · not yet recruiting
- NCT07407426 — EEG-Guided Binaural Beat Audio to Reduce Performance-Related Stress and Improve Cognition · NA · not yet recruiting
- NCT07434375 — Speech Intervention Via Telepractice for Children With Repaired Cleft Palate · NA · not yet recruiting
- NCT07451210 — Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitatio · NA · recruiting
- NCT07309874 — Effect of Ultrasound-Guided Dry Needling Targeting Rectus Capitus Posterior Major on Individuals With Headaches · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00818779 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Texas Tech University Health Sciences Center
- Last refreshed: 31 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00818779.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing