NCT00913653

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

December 19, 2020

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

June 2, 2009

Last Update Submit

December 16, 2020

Conditions

Heart Failure

Keywords

Heart failureLCZ696

Outcome Measures

Primary Outcomes (1)

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

    14 days

Secondary Outcomes (2)

  • Pharmacokinetics of LCZ696 and its metabolites

    14 days

  • Pharmacodynamics of LCZ696

    14 days

Study Arms (1)

Stable heart failure patients

EXPERIMENTAL
Drug: LCZ696

Interventions

LCZ696DRUG
Stable heart failure patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with documented heart failure (NYHA class II-IV)

You may not qualify if:

  • Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GOUVPO Russian Peoples´ Friendship University, Center of Applied

Moscow, 117198, Russia

Location

Related Publications (1)

  • 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.

    PMID: 26990595RESULT

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 4, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2009

Last Updated

December 19, 2020

Record last verified: 2016-11

Locations

RU(1)