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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
History of Changes
  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:

U.S. FDA Resources

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 May 16, 2013