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

Phase 2CompletedNCT00913653

Novartis Pharmaceuticals30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

LCZ696DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

GOUVPO Russian Peoples´ Friendship University, Center of Applied

Moscow, Russia

Outcomes

Primary Outcomes

Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696

Time frame: 14 days

Secondary Outcomes

Pharmacokinetics of LCZ696 and its metabolites

Time frame: 14 days

Pharmacodynamics of LCZ696

Time frame: 14 days

Data from ClinicalTrials.gov

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