Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment

Phase 1

Completed

• Conditions: Type-2 Diabetes
• Interventions: Drug: vildagliptin

• Registration Number: NCT00567047
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Primary Completion: 2009-01
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	vildagliptin	Vildagliptin

Primary Outcome Measures

Name	Time	Method
• Pharmacokinetic measures	throughout the study

Secondary Outcome Measures

Name	Time	Method
• Safety and tolerability measures	throughout the study

Trial Locations

Locations (1)

Novartis Investigator Site; 🇩🇪 Kiel, Germany