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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00446511 |
The purpose of this extension study is to compare the long term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with Chronic kidney disease (CKD). In addition it will evaluate proteinuria reduction, renopreservation, and tolerability of valsartan and enalapril combination vs. enalapril monotherapy alone in patients with chronic kidney disease.
Condition | Intervention | Phase |
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Hypertension |
Drug: Valsartan, enalapril |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients. |
Estimated Enrollment: | 300 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CVAL489K2302E1 |
Study First Received: | March 9, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00446511 |
Health Authority: | United States: Food and Drug Administration; Belgium : Federal Public Service, Health, Food Chain Safety & Environment; Czech Republic: State Institute for Drug Control; France : Agence Francaise de Sécurite Sanitair des produits de santé; Germany : Federal Institute for Drugs and Medical Devices (BfArM); Hungary: National Institute of Pharmacy; Italy : Italian Medicines Agency; Lithuania : State Medicines Control Agency; Poland : The Office for Registration of Medicinal Products,Medical Devices and Biocidal Products; Sweden : Läkemedelsverket Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Brazil: National Health Surveillance Agency; India : Central Drug Standard Control Organization; South Africa : Department of Health Affairs; Switzerland : Swissmedic - Agency for Therapeutic Products; Turkey : Turkey Ministry of Health |
Children pediatrics High Blood Pressure |
Hypertension Valsartan enalapril |
Enalapril Enalaprilat Renal Insufficiency, Chronic Vascular Diseases |
Kidney Failure, Chronic Kidney Diseases Valsartan Hypertension |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |