NCT01569828

Brief Summary

An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function

Trial Health

90
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

3 active sites

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

March 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

September 29, 2015

Completed
Last Updated

September 29, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

March 30, 2012

Results QC Date

July 30, 2015

Last Update Submit

August 27, 2015

Conditions

PharmacokineticsRenal ImpairedHealthy Volunteer

Keywords

LCZ696pharmacokinetics

Outcome Measures

Primary Outcomes (6)

  • Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)

    1 and 5 days

  • (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)

    1 and 5 days

  • AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)

    1 and 5 days

  • T1/2 After Multiple Dose Administration (Day 5)

    Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

    5 days

  • CL/F After Multiple Dose Administration (Day 5)

    Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

    5 days

  • CLr After Multiple Dose Administration (Day 5)

    Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

    5 days

Secondary Outcomes (1)

  • 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers

    5 days

Study Arms (2)

Renal Impaired Subjects

EXPERIMENTAL

once daily administration of 400 mg LCZ696 for 5 days

Drug: LCZ696A

Healthy Volunteers

EXPERIMENTAL

once daily administration of 400 mg LCZ696 for 5 days

Drug: LCZ696A

Interventions

LCZ696ADRUG
Renal Impaired Subjects

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Neuss, 41460, Germany

Location

Novartis Investigative Site

Moscow, 117292, Russia

Location

Novartis Investigative Site

Belgrade, Serbia

Location

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 29, 2015

Results First Posted

September 29, 2015

Record last verified: 2015-08

Locations

RU(1)DE(1)SE(1)