NCT01256411

A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	LCZ696	Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.
DRUG	Amlodipine	Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.
DRUG	Hydrochlorothiazide (HCTZ)	Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-12-08
• Last updated: 2015-10-21
• Results posted: 2015-10-21

Locations

33 sites across 5 countries: China, Japan, South Korea, Taiwan, Thailand