Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

• 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:

• Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline

Exclusion Criteria:

• Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg

• History of angioedema, drug-related or otherwise, as reported by the patient

• Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.

• Patients have significant cardiovascular co-morbidities

• 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.