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NCT00409578 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome
A Phase 2 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,101
- Enrollment target
NCT00409578: Completed Phase 2 study, sponsored by Novartis.
NCT00409578 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 1,101 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (728% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00409578, a Phase 2 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,101 participants
- Enrollment target
Study Summary
The purpose of this study is to test the hypothesis that the inhibition of the renin-angiotensin-aldosterone system (RAAS) with the angiotensin receptor blocker valsartan or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a greater reduction in levels of N-terminal proB-type natriuretic peptide (NT-proBNP) compared to placebo in subjects stabilized following acute coronary syndrome (ACS) who are determined to be at high risk due to an elevated concentration of natriuretic peptides.
Primary Outcome
Blood samples for the measurement of NT-proBNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.
Interventions
- DRUG Placebo
- DRUG Aliskiren 300 mg
- DRUG Valsartan 320 mg
- DRUG Aliskiren/valsartan 300/320 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,101 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00409578 record still lists
NCT00409578 is an interventional study that assigns participants to a tested intervention. Its 1,101 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (728% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00409578 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00409578 about?
NCT00409578 is a clinical study titled "Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome". The purpose of this study is to test the hypothesis that the inhibition of the renin-angiotensin-aldosterone system (RAAS) with the angiotensin receptor blocker valsartan or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a greater reduction in levels of N-termi...
What is the current status of trial NCT00409578?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,101 participants. The study started on 2007-02. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00409578?
The interventions under investigation include: Placebo (DRUG), Aliskiren 300 mg (DRUG), Valsartan 320 mg (DRUG), Aliskiren/valsartan 300/320 mg (DRUG).
Who is sponsoring clinical trial NCT00409578?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00409578's enrollment target sits among peer trials
1,101 21st of 2000 higher than 1,980 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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