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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 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 589 participants.

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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.

Interventions

  • DRUG Aliskiren

Trial Details

FieldValue
Enrollment Target 589 participants
Start Date 2012-04
Est. Completion 2012-11
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01570686

The ClinicalTrials.gov registry entry for NCT01570686 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 589 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 1 intervention - of which Aliskiren is the first listed.

NCT01570686 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.