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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
LCZ696
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, LCZ696

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • GOUVPO Russian Peoples´ Friendship University, Center of Applied

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stable heart failure patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics of LCZ696 and its metabolites
Pharmacodynamics of LCZ696

Full Information

First Posted
June 2, 2009
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00913653
Brief Title
Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure
Official Title
An Open Label, Non-randomised Study to Explore Safety/Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 in Patients With Stable Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, LCZ696

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stable heart failure patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LCZ696
Primary Outcome Measure Information:
Title
Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics of LCZ696 and its metabolites
Time Frame
14 days
Title
Pharmacodynamics of LCZ696
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
GOUVPO Russian Peoples´ Friendship University, Center of Applied
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
26990595
Citation
Kobalava Z, Kotovskaya Y, Averkov O, Pavlikova E, Moiseev V, Albrecht D, Chandra P, Ayalasomayajula S, Prescott MF, Pal P, Langenickel TH, Jordaan P, Rajman I. Pharmacodynamic and Pharmacokinetic Profiles of Sacubitril/Valsartan (LCZ696) in Patients with Heart Failure and Reduced Ejection Fraction. Cardiovasc Ther. 2016 Aug;34(4):191-8. doi: 10.1111/1755-5922.12183.
Results Reference
result
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3202
Description
Results for CLCZ696A2117 from the Novartis Clinical Trials Website

Learn more about this trial

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

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