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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00818571
First received: January 6, 2009
Last updated: September 23, 2010
Last verified: September 2010
History of Changes

January 6, 2009
September 23, 2010
December 2008
May 2009   (final data collection date for primary outcome measure)
Measure: pharmacokinetics of vildagliptin and its metabolites [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Measure: pharmacokinetics of vildagliptin modified release formulation and its metabolites [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00818571 on ClinicalTrials.gov Archive Site
Measure: safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Measure: safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients
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

This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Impairment
  • Diabetes
  • Drug: Vildagliptin
    Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
  • Drug: Vildagliptin
    Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
  • Drug: Vildagliptin
    Matching healthy volunteers receiving 25 mg vildagliptin once daily.
  • Drug: Vildagliptin
    Matching healthy volunteers receiving 50 mg vildagliptin once daily
  • Experimental: Vildagliptin 25 mg qd in RI patients
    Intervention: Drug: Vildagliptin
  • Experimental: Vildagliptin 50 mg qd in RI Patients
    Intervention: Drug: Vildagliptin
  • Experimental: Vildagliptin 25 mg qd in matched HV
    Intervention: Drug: Vildagliptin
  • Experimental: Vildagliptin 50 mg qd in matched HV
    Intervention: Drug: Vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
Not Provided
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00818571
CLAF237B2202, 2008-004565-25
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP