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

An Open Label, Non-randomised Study to Explore Safety/Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 in Patients With Stable Heart Failure

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00913653

Enrollment

Registered

2009-06-04

Start date

2009-05-31

Completion date

Unknown

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, LCZ696

Brief summary

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

Interventions

DRUGLCZ696

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696	14 days

Secondary

Measure	Time frame
Pharmacokinetics of LCZ696 and its metabolites	14 days
Pharmacodynamics of LCZ696	14 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026