We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818571
First Posted: January 7, 2009
Last Update Posted: February 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
January 6, 2009
January 7, 2009
February 5, 2016
December 2008
May 2009   (Final data collection date for primary outcome measure)
Measure: pharmacokinetics of vildagliptin and its metabolites [ Time Frame: 14 days ]
Measure: pharmacokinetics of vildagliptin modified release formulation and its metabolites [ Time Frame: 14 days ]
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 ]
Same as current
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: Parallel Assignment
Masking: None (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 Renal Impaired (RI) patients
    Intervention: Drug: Vildagliptin
  • Experimental: Vildagliptin 50 mg qd in RI Patients
    Intervention: Drug: Vildagliptin
  • Experimental: Vildagliptin 25 mg qd in matched Healthy Volunteer (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

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT00818571
CLAF237B2202
2008-004565-25 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2016

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