Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00567047 |
This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.
Condition | Intervention | Phase |
---|---|---|
Type-2 Diabetes |
Drug: vildagliptin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment |
Official Title: | An Open-Label, Parallel-Group Study to Determine the Single and Multiple Dose Pharmacokinetics of Vildagliptin and Its Metabolites in Mild, Moderate or Severe Renal Impaired Patients Compared to Age, Sex and Weight-Matched Healthy Volunteers Following Daily Doses of 50 mg Vildagliptin for 14 Days |
Estimated Enrollment: | 96 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Vildagliptin
|
Drug: vildagliptin |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (general):
Inclusion Criteria (for renal insufficient patients):
Inclusion Criteria (for healthy subjects):
oral body temperature between 35.0-37.2 °C systolic blood pressure, 100-140 mm Hg diastolic blood pressure, 60-110 mm Hg pulse rate, 45-90 bpm
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contact: NOVARTIS | 862-778-8300 |
United States, Florida | |
Novartis Investigator Site | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: NOVARTIS 862-778-8300 | |
Novartis Investigator Site | Recruiting |
Orlando, Florida, United States, 32809 | |
Contact: NOVARTIS 862-778-8300 | |
United States, Minnesota | |
Novartis Investigator Site | Recruiting |
Minneapolis, Minnesota, United States, 55404 | |
Contact: NOVARTIS 862-778-8300 | |
United States, Tennessee | |
Novartis Investigator Site | Recruiting |
Knoxville, Tennessee, United States, 37920 | |
Contact: NOVARTIS 862-778-8300 | |
United States, Virginia | |
Novartis Investigator Site | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: NOVARTIS 862-778-8300 | |
Germany | |
Novartis Investigator Site | Recruiting |
Kiel, Germany | |
Contact: NOVARTIS +41 61 324 1111 |
Principal Investigator: | Novartis | Novartis investigative site |
Responsible Party: | Novartis ( Novartis ) |
Study ID Numbers: | CLAF237A2115 |
Study First Received: | December 3, 2007 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00567047 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
Body Weight Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Healthy Metabolic disorder Glucose Metabolism Disorders Vildagliptin |
Dipeptidyl-Peptidase IV Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |