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

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: LCZ696

• Registration Number: NCT00913653
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2009-07
• Status Verified: 2016-11
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stable heart failure patients	LCZ696	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of LCZ696 and its metabolites	14 days
Pharmacodynamics of LCZ696	14 days

Trial Locations

Locations (1)

GOUVPO Russian Peoples´ Friendship University, Center of Applied; 🇷🇺 Moscow, Russian Federation