A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Novartis

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: Hydrochlorothiazide (HCTZ); Drug: Amlodipine; Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01256411

CLCZ696A2219E1

Details and patient eligibility

About

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Enrollment: 341 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
• Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

Exclusion criteria

• Patients who did not complete CLCZ696A2219.
• Presence of significant protocol violation in CLCZ696A2219.
• Patients who are deemed to be unable to comply with the protocol by the investigator.
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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341 participants in 1 patient group

LCZ696

Experimental group

Treatment:

Drug: Hydrochlorothiazide (HCTZ)

Drug: LCZ696

Drug: Amlodipine