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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00464776 |
This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2 diabetes patients with incipient or overt nephropathy
Condition | Intervention | Phase |
---|---|---|
Diabetes Type 2 |
Drug: Aliskiren |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Cross-Over, 4-Period, 4 Treatment, Within-Subject Placebo-Controlled Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Type 2 Diabetic Patients With Incipient or Overt Nephropathy |
Estimated Enrollment: | 24 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Various sequences of 3 doses of Aliskiren plus placebo
|
Drug: Aliskiren |
2: Experimental
Various sequences of 3 doses of Aliskiren plus placebo
|
Drug: Aliskiren |
3: Experimental
Various sequences of 3 doses of Aliskiren plus placebo
|
Drug: Aliskiren |
4: Experimental
Various sequences of 3 doses of Aliskiren plus placebo
|
Drug: Aliskiren |
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible for randomization, patients must fulfill the following criteria:
Exclusion Criteria:
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
Other protocol-defined inclusion/exclusion criteria may apply
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSPP100A2240 |
Study First Received: | April 21, 2007 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00464776 |
Health Authority: | Denmark: Danish Medicines Agency |
Randomized double-blind cross-over 4-period 4 treatment |
within-subject placebo-controlled study assess optimal renoprotective dose of Aliskiren hypertensive type 2 diabetes patients incipient or overt nephropathy |
Metabolic Diseases Urologic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Kidney Diseases Metabolic disorder Glucose Metabolism Disorders |