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

Phase 2CompletedNCT01256411

Novartis Pharmaceuticals341 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

341

Conditions

Essential Hypertension

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (33)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)

Participants were monitored throughout the study for adverse events, serious adverse events and deaths.

Time frame: Baseline to 12 months

Secondary Outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)

Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.

Time frame: Baseline, 12 months

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)

Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.

Time frame: Baseline, 12 months

Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)

Blood pressure (BP) control is defined as BP \<140/90 mmHg.

Time frame: Baseline to 12 months

Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)

Blood pressure (BP) control is defined as BP \<140/90 mmHg.

Time frame: Baseline to 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Novartis Investigative Site

Chongqing, Chongqing Municipality, China

Novartis Investigative Site

Shijiazhuang, Hebei, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Shimotsuke, Tochigi, Japan

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site

Chiyoda-ku, Tokyo, Japan

...and 23 more locations