NCT01663233

Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine

A Randomized, 8-week, Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 5 mg Monotherapy Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not adequately responsive to amlodipine therapy.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	LCZ696	LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.
DRUG	Amlodipine	Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.
DRUG	Placebo	Matching placebo to LCZ696

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-08-13
• Last updated: 2015-10-23
• Results posted: 2015-08-18

Locations

28 sites across 6 countries: China, Japan, Malaysia, Philippines, South Korea, Taiwan