CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 341 enrolled
Drug / intervention
LCZ696 +2 moredrug
Likely dose
LCZ696 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01256411
NCT01256411Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Dec 8, 2010·Updated Oct 21, 2015

In Brief

A Phase 2 clinical trial evaluating LCZ696, Amlodipine, and 1 other intervention for Essential Hypertension. Completed, enrolled 341 participants across 33 sites in 5 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Hypertension
CountriesChina, Japan, South Korea, Taiwan, Thailand
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2010
Enrollment StartNov 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.6 years ago

Interventions

LCZ696drug

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.

Amlodipinedrug

Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Hydrochlorothiazide (HCTZ)drug

Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.