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Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients

NCT ID: NCT00818571

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients

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Detailed Description

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Conditions

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Renal Impairment Diabetes

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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Vildagliptin 25 mg qd in Renal Impaired (RI) patients

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily

Vildagliptin 50 mg qd in RI Patients

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily

Vildagliptin 25 mg qd in matched Healthy Volunteer (HV)

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Matching healthy volunteers receiving 25 mg vildagliptin once daily.

Vildagliptin 50 mg qd in matched HV

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Matching healthy volunteers receiving 50 mg vildagliptin once daily

Interventions

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Vildagliptin

Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily

Intervention Type DRUG

Vildagliptin

Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily

Intervention Type DRUG

Vildagliptin

Matching healthy volunteers receiving 25 mg vildagliptin once daily.

Intervention Type DRUG

Vildagliptin

Matching healthy volunteers receiving 50 mg vildagliptin once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to \<50 ml/min) and severe (CrCl of \<30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of \>80 ml/min

Exclusion Criteria

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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 Investigator Site

Moscow, , Russia

Site Status

Countries

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Russia

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2949

Results for CLAF237B2202 from the Novartis Clinical Trials website

Other Identifiers

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2008-004565-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLAF237B2202

Identifier Type: -

Identifier Source: org_study_id

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