Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

August 7, 2015 updated by: Novartis Pharmaceuticals

A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

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

  • Japan
      • Osaka, Japan, 536-0008
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0026
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 003-0825
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 063-0842
        • Novartis Investigative Site
    • Kagoshima
      • Aira-city, Kagoshima, Japan, 899-5431
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki-city, Kanagawa, Japan, 210-0852
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 231-0023
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japan, 980-8574
        • Novartis Investigative Site
    • Okayama
      • Kurashiki, Okayama, Japan, 701-0192
        • Novartis Investigative Site
    • Saitama
      • Fujimino, Saitama, Japan, 356-0053
        • Novartis Investigative Site
    • Tokyo
      • Hachioji-city, Tokyo, Japan, 192-0918
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 108-0075
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 141-0032
        • 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.
  • Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline.

Exclusion Criteria:

  • Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.
  • History of angioedema, drug-related or otherwise, as reported by the patient.
  • Any other following renal disorder:
  • Patients show eGFR < 15mL/min/1.73m^2
  • Patients on dialysis
  • Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LCZ696 100 mg
All participants were started on LCZ696 100 mg once daily on day 1.
Drug: LCZ696
100 mg, 200 mg, 400 mg tablets.
Experimental: LCZ696 200 mg
All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
Drug: LCZ696
100 mg, 200 mg, 400 mg tablets.
Experimental: LCZ696 400 mg
All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
Drug: LCZ696
100 mg, 200 mg, 400 mg tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)
Time Frame: 8 weeks
Percentage of patients with total adverse events, serious adverse events and death were reported.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
Time Frame: baseline, 8 weeks
Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements.
baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8
Time Frame: baseline, 8 weeks
baseline, 8 weeks
Percentage of Participants Achieving a Successful BP Control at Week 8
Time Frame: 8 weeks
A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg
8 weeks
Percentage of Participants Achieving SBP Control at Week 8
Time Frame: 8 weeks
SBP control was defined as msSBP <130 mmHg.
8 weeks
Percentage of Participants Achieving DBP Control at Week 8
Time Frame: 8 weeks
DBP control was defined as msDBP <80 mmHg.
8 weeks
Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8
Time Frame: 8 weeks
Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline
8 weeks
Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8
Time Frame: 8 weeks
Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.
8 weeks

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCZ696A1304

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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