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NCT00549757 · ClinicalTrials.gov registry record · Phase 3
Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 8,606
- Enrollment target
NCT00549757: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00549757 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 8,606 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1016% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00549757, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 8,606 participants
- Enrollment target
Study Summary
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. AMENDMENT 4 RATIONALE (MARCH 2012) : Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.
Primary Outcome
Occurrence was defined as the first event of the following composite primary endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF) * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
Interventions
- DRUG Placebo
- DRUG Aliskiren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,606 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
Why NCT00549757 stopped before completion
NCT00549757 is an interventional study that assigns participants to a tested intervention. Its 8,606 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1016% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00549757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00549757 about?
NCT00549757 is a clinical study titled "Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)". The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease ...
What is the current status of trial NCT00549757?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 8,606 participants. The study started on 2007-10. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00549757?
The interventions under investigation include: Placebo (DRUG), Aliskiren (DRUG).
Who is sponsoring clinical trial NCT00549757?
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 NCT00549757's enrollment target sits among peer trials
8,606 32nd of 2000 higher than 1,969 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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