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

NCT01281306 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 910

Last updated 2016-01-29

Study results available
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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).

Conditions

  • Systolic Hypertension

Interventions

DRUG

LCZ696

LCZ696 was supplied as tablets in blister cards in 100 mg strengths.

DRUG

Valsartan

Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.

DRUG

AHU377

AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.

DRUG

Placebo

Placebo was supplied as tablets in blister cards.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Argentina
  • Canada
  • Hungary
  • India
  • Romania
  • Slovakia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01281306 on ClinicalTrials.gov