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

Phase 3

Completed

• Conditions: Hypertension With Renal Dysfunction
• Interventions: Drug: LCZ696

• Registration Number: NCT01593787
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-30
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2015-07-08
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-07
• Last Update Submitted: 2015-08-07
• Results First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCZ696 100 mg	LCZ696	All participants were started on LCZ696 100 mg once daily on day 1.
LCZ696 400 mg	LCZ696	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.
LCZ696 200 mg	LCZ696	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)	8 weeks	Percentage of patients with total adverse events, serious adverse events and death were reported.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8	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.
Percentage of Participants Achieving DBP Control at Week 8	8 weeks	DBP control was defined as msDBP \<80 mmHg.
Percentage of Participants Achieving a Successful BP Control at Week 8	8 weeks	A successful BP control was defined as msSBP \<130 mmHg and msDBP \<80 mmHg
Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8	8 weeks	Successful response rate was defined as msSBP \<130 mmHg or a reduction of ≥20 mmHg from baseline
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8	baseline, 8 weeks
Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8	8 weeks	Successful response rate was defined as msDBP \<80 mmHg or a reduction of ≥10 mmHg from baseline.
Percentage of Participants Achieving SBP Control at Week 8	8 weeks	SBP control was defined as msSBP \<130 mmHg.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Osaka, Japan