Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure

Novartis

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913653

CLCZ696A2117

Details and patient eligibility

About

This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with documented heart failure (NYHA class II-IV)

Exclusion criteria

• Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Stable heart failure patients

Experimental group

Treatment:

Drug: LCZ696