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

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: LCZ696; Drug: Amlodipine; Drug: Hydrochlorothiazide (HCTZ)

• Registration Number: NCT01256411
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2015-07-21
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-22
• Last Update Submitted: 2015-09-22
• Results First Posted: 2015-10-21
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

• Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
• Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

Exclusion Criteria

• Patients who did not complete CLCZ696A2219.
• Presence of significant protocol violation in CLCZ696A2219.
• Patients who are deemed to be unable to comply with the protocol by the investigator.
• Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCZ696	LCZ696	-
LCZ696	Hydrochlorothiazide (HCTZ)	-
LCZ696	Amlodipine	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)	Baseline to 12 months	Participants were monitored throughout the study for adverse events, serious adverse events and deaths.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)	Baseline, 12 months	Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)	Baseline, 12 months	Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.
Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)	Baseline to 12 months	Blood pressure (BP) control is defined as BP \<140/90 mmHg.
Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)	Baseline to 12 months	Blood pressure (BP) control is defined as BP \<140/90 mmHg.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇭 Chiang Mai, Thailand