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| Sponsored by: |
Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00433836 |
Purpose
The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Valsartan Drug: Enalapril |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension |
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Valsartan 80 mg: Experimental | Drug: Valsartan |
| Valsartan 160 mg: Experimental | Drug: Valsartan |
| Valsartan 320 mg: Experimental | Drug: Valsartan |
| Enalapril 10 mg: Active Comparator | Drug: Enalapril |
| Enalapril 20 mg: Active Comparator | Drug: Enalapril |
| Enalapril 40 mg: Active Comparator | Drug: Enalapril |
Eligibility| 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
Contacts and Locations| Contact: Novartis Pharmaceuticals | 862-778-8300 | |
| Contact: Novartis Pharmaceuticals | Novartis: 41 61 324 1111 |
Show 19 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CVAL489K2302 |
| Study First Received: | February 8, 2007 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00433836 History of Changes |
| 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: BfArM; Hungary: National Institute of Pharmacy; Italy: Italian Medicines Agency; Lithuania: State Medicines Control Agency; Poland: The Office for Registration of Medicinal Products; Poland: Medical Devices and Biocidal Products; Sweden: Läkemedelsverket Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnologia Medica; Austrailia: Department of Health & Ageing; Brazil: National Health Surveillance Agency; Chile: Instituto de Salud Pública de Chile; India: Central Drug Standard Control Organisation; New Zealand: MEDSAFE - New Zealand Medicines and Medical Devices Safety Authority; 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 Vascular Diseases Angiotensin-Converting Enzyme Inhibitors Cardiovascular Agents |
Antihypertensive Agents Valsartan Protease Inhibitors Hypertension |
|
Molecular Mechanisms of Pharmacological Action Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |
Enalapril Enalaprilat Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Valsartan Hypertension |