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

Primary Purpose

Hypertension With Renal Dysfunction

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
LCZ696
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension With Renal Dysfunction focused on measuring Hypertension, Renal dysfunction, LCZ696

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LCZ696 100 mg

LCZ696 200 mg

LCZ696 400 mg

Arm Description

All participants were started on LCZ696 100 mg once daily on day 1.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)
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
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
Percentage of Participants Achieving a Successful BP Control at Week 8
A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg
Percentage of Participants Achieving SBP Control at Week 8
SBP control was defined as msSBP <130 mmHg.
Percentage of Participants Achieving DBP Control at Week 8
DBP control was defined as msDBP <80 mmHg.
Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8
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
Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.

Full Information

First Posted
April 30, 2012
Last Updated
August 7, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01593787
Brief Title
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension With Renal Dysfunction
Keywords
Hypertension, Renal dysfunction, LCZ696

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCZ696 100 mg
Arm Type
Experimental
Arm Description
All participants were started on LCZ696 100 mg once daily on day 1.
Arm Title
LCZ696 200 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
LCZ696 400 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LCZ696
Intervention Description
100 mg, 200 mg, 400 mg tablets.
Primary Outcome Measure Information:
Title
Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)
Description
Percentage of patients with total adverse events, serious adverse events and death were reported.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
Description
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.
Time Frame
baseline, 8 weeks
Title
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8
Time Frame
baseline, 8 weeks
Title
Percentage of Participants Achieving a Successful BP Control at Week 8
Description
A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg
Time Frame
8 weeks
Title
Percentage of Participants Achieving SBP Control at Week 8
Description
SBP control was defined as msSBP <130 mmHg.
Time Frame
8 weeks
Title
Percentage of Participants Achieving DBP Control at Week 8
Description
DBP control was defined as msDBP <80 mmHg.
Time Frame
8 weeks
Title
Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8
Description
Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline
Time Frame
8 weeks
Title
Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8
Description
Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
063-0842
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0026
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0825
Country
Japan
Facility Name
Novartis Investigative Site
City
Aira-city
State/Province
Kagoshima
ZIP/Postal Code
899-5431
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawasaki-city
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
231-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Sendai-city
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Novartis Investigative Site
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
Novartis Investigative Site
City
Fujimino
State/Province
Saitama
ZIP/Postal Code
356-0053
Country
Japan
Facility Name
Novartis Investigative Site
City
Hachioji-city
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Novartis Investigative Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0032
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
536-0008
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25693859
Citation
Ito S, Satoh M, Tamaki Y, Gotou H, Charney A, Okino N, Akahori M, Zhang J. Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Hypertens Res. 2015 Apr;38(4):269-75. doi: 10.1038/hr.2015.1. Epub 2015 Feb 19.
Results Reference
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Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

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