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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00461136 |
This study will evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
Condition | Intervention | Phase |
---|---|---|
Diabetes Type 2 |
Drug: Aliskiren |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | An Open-Label, One-Period, One-Treatment Study to Evaluate the Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes Suffering From Incipient and/or Established Nephropathy |
Estimated Enrollment: | 18 |
Study Start Date: | August 2005 |
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
-Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1 Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
Other protocol-defined inclusion/exclusion criteria may apply
Study ID Numbers: | CSPP100A2242 |
Study First Received: | April 16, 2007 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00461136 |
Health Authority: | Denmark: Danish Medicines Agency |
Time course antiproteinuric blood pressure lowering effect |
initiation of renin inhibition Aliskiren in Type 2 diabetes incipient and/or established nephropathy |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Kidney Diseases Metabolic disorder Glucose Metabolism Disorders |