ong term study of safety and efficacy of LCZ696 and LCZ696 combination with amlodipine in patients with hypertensio

Phase 1

• Conditions: Essential hypertension; MedDRA version: 16.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002306-31-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-11
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Written informed consent for the extension must be obtained before any assessment is performed.
2. Patients who have successfully completed protocol CLCZ696A2320 and are able to safely continue into the open-label extension as judged by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 476
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 124

Exclusion Criteria

1. Patients who experienced a serious drug-related adverse event in study CLCZ696A2320.
2. Patients who develop a condition during the core study that would have excluded them from participation in the core study.
3. Patients with hypersensitivity to thiazide diuretics.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified