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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension With Renal Dysfunction

Treatments: Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01593787

CLCZ696A1304

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 3 patient groups

LCZ696 100 mg

Experimental group

Description:

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

Treatment:

Drug: LCZ696

LCZ696 200 mg

Experimental group

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.

Treatment:

Drug: LCZ696

LCZ696 400 mg

Experimental group

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.

Treatment:

Drug: LCZ696