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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination

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.