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

September 22, 2015 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

341

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Novartis Investigative Site
      • Beijing, China, 100730
        • Novartis Investigative Site
      • Tianjin, China, 300142
        • Novartis Investigative Site
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Novartis Investigative Site
  • Japan
    • Kanagawa
      • Yokohama-city, Kanagawa, Japan, 231-0023
        • Novartis Investigative Site
    • Tochigi
      • Shimotsuke-city, Tochigi, Japan, 329-0498
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-0031
        • Novartis Investigative Site
      • Chiyoda-ku, Tokyo, Japan, 100-0005
        • Novartis Investigative Site
      • Kiyose-city, Tokyo, Japan, 204-0021
        • Novartis Investigative Site
      • Kunitachi, Tokyo, Japan, 186-0001
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 105-7390
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 108-0075
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 143-0023
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 141-0032
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 142-0053
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 142-0063
        • Novartis Investigative Site
      • Toshima-ku, Tokyo, Japan, 171-0021
        • Novartis Investigative Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-703
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 150-950
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 152-703
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 424-717
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 137-701
        • Novartis Investigative Site
    • Kyunggi
      • Koyang, Kyunggi, Korea, Republic of, 410-719
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
      • Taipei, Taiwan, 10449
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LCZ696
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (Estimate)

December 8, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCZ696A2219E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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