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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01593787
First received: April 30, 2012
Last updated: August 7, 2015
Last verified: August 2015
  Purpose

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


Condition Intervention Phase
Hypertension With Renal Dysfunction
Drug: LCZ696
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Percentage of patients with total adverse events, serious adverse events and death were reported.


Secondary Outcome Measures:
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving a Successful BP Control at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg

  • Percentage of Participants Achieving SBP Control at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    SBP control was defined as msSBP <130 mmHg.

  • Percentage of Participants Achieving DBP Control at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    DBP control was defined as msDBP <80 mmHg.

  • Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline

  • Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.


Enrollment: 32
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593787

Locations
Japan
Novartis Investigative Site
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
Aira-city, Kagoshima, Japan, 899-5431
Novartis Investigative Site
Kawasaki-city, Kanagawa, Japan, 210-0852
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 231-0023
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site
Kurashiki, Okayama, Japan, 701-0192
Novartis Investigative Site
Fujimino, Saitama, Japan, 356-0053
Novartis Investigative Site
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
Osaka, Japan, 536-0008
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01593787     History of Changes
Other Study ID Numbers: CLCZ696A1304
Study First Received: April 30, 2012
Results First Received: July 8, 2015
Last Updated: August 7, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Hypertension
Renal dysfunction
LCZ696

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 26, 2015