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NCT01259297 · ClinicalTrials.gov registry record · Phase 3
A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,336
- Enrollment target
NCT01259297: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01259297 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 2,336 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (203% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01259297, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,336 participants
- Enrollment target
Study Summary
This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.
Primary Outcome
The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure
Interventions
- DRUG Amlodipine
- DRUG Aliskiren
- DRUG Placebo for Aliskiren
- DRUG Hydrochlorothiazide (HCTZ)
- DRUG Placebo for Amlodipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,336 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
Why NCT01259297 stopped before completion
NCT01259297 is an interventional study that assigns participants to a tested intervention. Its 2,336 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 (203% higher).
The record links to 0 conditions, and to 5 interventions - of which Amlodipine is the first listed.
NCT01259297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01259297 about?
NCT01259297 is a clinical study titled "A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People". This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) e...
What is the current status of trial NCT01259297?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,336 participants. The study started on 2011-01. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01259297?
The interventions under investigation include: Amlodipine (DRUG), Aliskiren (DRUG), Placebo for Aliskiren (DRUG), Hydrochlorothiazide (HCTZ) (DRUG), Placebo for Amlodipine (DRUG).
Who is sponsoring clinical trial NCT01259297?
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 NCT01259297's enrollment target sits among peer trials
2,336 92nd of 2000 higher than 1,909 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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