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Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function

NCT ID: NCT01569828

Last Updated: 2015-09-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Pharmacokinetics Renal Impaired Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Impaired Subjects

once daily administration of 400 mg LCZ696 for 5 days

Group Type EXPERIMENTAL

LCZ696A

Intervention Type DRUG

Healthy Volunteers

once daily administration of 400 mg LCZ696 for 5 days

Group Type EXPERIMENTAL

LCZ696A

Intervention Type DRUG

once daily administration of 400 mg LCZ696 for 5 days

Interventions

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LCZ696A

Intervention Type DRUG

LCZ696A

once daily administration of 400 mg LCZ696 for 5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Neuss, , Germany

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Belgrade, , Serbia

Site Status

Countries

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Germany Russia Serbia

Other Identifiers

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2007-005482-36

Identifier Type: -

Identifier Source: secondary_id

CLCZ696A2205

Identifier Type: -

Identifier Source: org_study_id

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