NCT01281306

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 Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg After 8 Week Treatment in Patients With Mild-to-moderate Systolic Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 910 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-01-21
• Last updated: 2016-01-29
• Results posted: 2015-08-18

Locations

90 sites across 9 countries: United States, Argentina, Canada, Hungary, India, Romania, Slovakia, South Korea, Spain