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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2012

Last Updated Date

August 7, 2015

Start Date ^ICMJE

May 2012

Primary Completion Date

March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Number of participants with reported adverse events ( total adverse events, serious adverse events and death) [ Time Frame: 8 weeks ]

Summerized report on adverse events such as number of patients with total adeverse events, serious adverse events and death will be reported.

Change History

Complete list of historical versions of study NCT01593787 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 [ Time Frame: 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
Percentage of Participants Achieving SBP Control at Week 8 [ Time Frame: 8 weeks ]
SBP control was defined as msSBP <130 mmHg.
Percentage of Participants Achieving DBP Control at Week 8 [ Time Frame: 8 weeks ]
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 ]
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 ]
Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.

Original Secondary Outcome Measures ^ICMJE

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 ]
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 ]
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 ]
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 ]
Successful response rate is defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension With Renal Dysfunction

Intervention ^ICMJE

Drug: LCZ696

100 mg, 200 mg, 400 mg tablets.

Study Arms

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

Intervention: Drug: LCZ696
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.

Intervention: Drug: LCZ696
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.

Intervention: Drug: LCZ696

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

March 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Japan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01593787

Other Study ID Numbers ^ICMJE

CLCZ696A1304

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

PRS Account

Novartis

Verification Date

August 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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