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: March 25, 2013
Last verified: March 2013
  Purpose

This study will assess 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:
  • Number of participants with reported adverse events ( total adverse events, serious adverse events and death) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Summerized report on adverse events such as number of patients with total adeverse events, serious adverse events and death will be reported.


Secondary Outcome Measures:
  • Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting Diastolic Blood Pressure (msDBP) at week 8 [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    Sitting BP measurements will be performed at screening through the end of study at every visit. Four separate sitting BP will be obtained with a full two-minute interval between measurements.

  • Percentage of patients achieving a successful BP control at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A successful BP control is defined as msSBP <130 mmHg and msDBP <80 mmHg

  • Percentage of patients achieving a successful response rate in msSBP at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful response rate is defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline

  • Percentage of patients achieving a successful response rate in msDBP at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful response rate is defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.


Enrollment: 40
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
Patients will receive the first dose of LCZ696 (100 mg once daily). The dose of LCZ696 will be increased up to 400 mg based on patients' condition.
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 on renal failure
  • 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
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, Kanagawa, Japan, 210-0852
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 231-0023
Novartis Investigative Site
Sendai, 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01593787     History of Changes
Other Study ID Numbers: CLCZ696A1304
Study First Received: April 30, 2012
Last Updated: March 25, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Hypertension
Renal dysfunction
LCZ696

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014