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NCT00894387 · ClinicalTrials.gov registry record · Phase 3
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,639
- Enrollment target
NCT00894387: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00894387 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,639 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00894387, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,639 participants
- Enrollment target
Study Summary
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.
Primary Outcome
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.
Interventions
- DRUG Placebo
- DRUG Aliskiren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,639 participants |
| Start Date | 2009-05 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT00894387 record still lists
NCT00894387 is an interventional study that assigns participants to a tested intervention. Its 1,639 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (112% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00894387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00894387 about?
NCT00894387 is a clinical study titled "Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure". This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated ...
What is the current status of trial NCT00894387?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,639 participants. The study started on 2009-05. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00894387?
The interventions under investigation include: Placebo (DRUG), Aliskiren (DRUG).
Who is sponsoring clinical trial NCT00894387?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00894387's enrollment target sits among peer trials
1,639 141st of 2000 higher than 1,860 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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