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NCT01281306 · ClinicalTrials.gov registry record · Phase 2

An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
910
Enrollment target

NCT01281306: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT01281306 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 910 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (584% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01281306, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
910 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).

Primary Outcome

Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

Interventions

  • DRUG Placebo
  • DRUG Valsartan
  • DRUG LCZ696
  • DRUG AHU377

Trial Details

FieldValue
Enrollment Target 910 participants
Start Date 2011-01
Est. Completion 2011-12
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01281306 record still lists

NCT01281306 is an interventional study that assigns participants to a tested intervention. The registered 910 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (584% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01281306 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01281306 about?

NCT01281306 is a clinical study titled "An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension". The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).

What is the current status of trial NCT01281306?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 910 participants. The study started on 2011-01. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01281306?

The interventions under investigation include: Placebo (DRUG), Valsartan (DRUG), LCZ696 (DRUG), AHU377 (DRUG).

Who is sponsoring clinical trial NCT01281306?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01281306's enrollment target sits among peer trials

910 30th of 2000 higher than 1,971 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01281306, the US trial registry maintained by the National Library of Medicine. NCT01281306 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.