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NCT01570686 · ClinicalTrials.gov registry record · Phase 4
8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 589
- Enrollment target
NCT01570686: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01570686 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 589 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01570686, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 589 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.
Primary Outcome
24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.
Interventions
- DRUG Aliskiren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 589 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
What the finished NCT01570686 record still lists
NCT01570686 is an interventional study that assigns participants to a tested intervention. The registered 589 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 1 intervention - of which Aliskiren is the first listed.
NCT01570686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01570686 about?
NCT01570686 is a clinical study titled "8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension". The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.
What is the current status of trial NCT01570686?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 589 participants. The study started on 2012-04. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01570686?
The interventions under investigation include: Aliskiren (DRUG).
Who is sponsoring clinical trial NCT01570686?
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 NCT01570686's enrollment target sits among peer trials
589 148th of 2000 higher than 1,853 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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