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

Condition Intervention Phase
Renal Impairment Diabetes Drug: Vildagliptin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Measure: pharmacokinetics of vildagliptin and its metabolites [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Measure: safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 14 days ]

Enrollment: 96
Study Start Date: December 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin 25 mg qd in Renal Impaired (RI) patients Drug: Vildagliptin
Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
Experimental: Vildagliptin 50 mg qd in RI Patients Drug: Vildagliptin
Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
Experimental: Vildagliptin 25 mg qd in matched Healthy Volunteer (HV) Drug: Vildagliptin
Matching healthy volunteers receiving 25 mg vildagliptin once daily.
Experimental: Vildagliptin 50 mg qd in matched HV Drug: Vildagliptin
Matching healthy volunteers receiving 50 mg vildagliptin once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818571


Locations
Russian Federation
Novartis Investigator Site
Moscow, Russian Federation
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00818571     History of Changes
Other Study ID Numbers: CLAF237B2202
2008-004565-25 ( EudraCT Number )
First Submitted: January 6, 2009
First Posted: January 7, 2009
Last Update Posted: February 5, 2016
Last Verified: January 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal impairment
Diabetes
vildagliptin
Galvus
Eucreas

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs


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