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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004565-25 | EudraCT Number |
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This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin 25 mg qd in Renal Impaired (RI) patients | Experimental |
| |
| Vildagliptin 50 mg qd in RI Patients | Experimental |
| |
| Vildagliptin 25 mg qd in matched Healthy Volunteer (HV) | Experimental |
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| Vildagliptin 50 mg qd in matched HV | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure: pharmacokinetics of vildagliptin and its metabolites | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: safety assessments will include vital signs, electrocardiograms and adverse events | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Moscow | Russia |
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| Label | URL |
|---|---|
| Results for CLAF237B2202 from the Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Vildagliptin | Drug | Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily |
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| Vildagliptin | Drug | Matching healthy volunteers receiving 25 mg vildagliptin once daily. |
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| Vildagliptin | Drug | Matching healthy volunteers receiving 50 mg vildagliptin once daily |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |