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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 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 8,606 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00549757
The ClinicalTrials.gov registry entry for NCT00549757 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 8,606 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00549757 reports 0 study locations.
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.
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