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NCT00818571 Clinical Trial

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

Diabetes Clinical Trial

Official title:
An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00818571
Other study ID # CLAF237B2202
Secondary ID 2008-004565-25
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2008

Study information
Verified date January 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin
Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
• Vildagliptin
Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
• Vildagliptin
Matching healthy volunteers receiving 25 mg vildagliptin once daily.
• Vildagliptin
Matching healthy volunteers receiving 50 mg vildagliptin once daily

Locations
Country Name City State
Russian Federation Novartis Investigator Site Moscow

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure: pharmacokinetics of vildagliptin and its metabolites 14 days
Secondary Measure: safety assessments will include vital signs, electrocardiograms and adverse events 14 days
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