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OpenTrials
Completed

NCT Number: NCT00913653

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

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

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GOUVPO Russian Peoples´ Friendship University, Center of Applied

Moscow, 117198, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCZ696

Drug

Primary outcomes

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

    Time frame: 14 days

Secondary outcomes

  1. Pharmacokinetics of LCZ696 and its metabolites

    Time frame: 14 days

  2. Pharmacodynamics of LCZ696

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
First posted
Jun 4, 2009
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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