- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01151410
An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
A Multicenter, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Bratislava, Eslovaquia, 85107
- Novartis Investigative Site
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Bratislava, Eslovaquia, 84103
- Novartis Investigative Site
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Martin, Eslovaquia, 03601
- Novartis Investigative Site
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Myjava, Eslovaquia, 90701
- Novartis Investigative Site
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Presov, Eslovaquia, 08001
- Novartis Investigative Site
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Trnava, Eslovaquia, 91701
- Novartis Investigative Site
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-0006
- Novartis Investigative Site
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72202
- Novartis Investigative Site
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California
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Los Angeles, California, Estados Unidos, 90048
- Novartis Investigative Site
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Georgia
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Dalton, Georgia, Estados Unidos, 30721
- Novartis Investigative Site
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Idaho
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Lewiston, Idaho, Estados Unidos, 83501
- Novartis Investigative Site
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Illinois
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Park Ridge, Illinois, Estados Unidos, 60068
- Novartis Investigative Site
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Novartis Investigative Site
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Mississippi
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Hattiesburg, Mississippi, Estados Unidos, 39401
- Novartis Investigative Site
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Jackson, Mississippi, Estados Unidos, 39209
- Novartis Investigative Site
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New York
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New York, New York, Estados Unidos, 10016
- Novartis Investigative Site
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Ohio
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Columbus, Ohio, Estados Unidos, 43205
- Novartis Investigative Site
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Toledo, Ohio, Estados Unidos, 43606
- Novartis Investigative Site
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Oregon
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Portland, Oregon, Estados Unidos, 97225
- Novartis Investigative Site
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Portland, Oregon, Estados Unidos, 07227
- Novartis Investigative Site
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Novartis Investigative Site
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Novartis Investigative Site
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25304
- Novartis Investigative Site
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Guatemala City, Guatemala, 01010
- Novartis Investigative Site
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Budapest, Hungría, 1083
- Novartis Investigative Site
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Budapest, Hungría, 1131
- Novartis Investigative Site
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Debrecen, Hungría, 4032
- Novartis Investigative Site
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Miskolc, Hungría, 3529
- Novartis Investigative Site
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Nyiregyhaza, Hungría, 4400
- Novartis Investigative Site
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Szeged, Hungría, 6725
- Novartis Investigative Site
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Veszprem, Hungría, H-8200
- Novartis Investigative Site
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Ankara, Pavo, 06100
- Novartis Investigative Site
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Ankara, Pavo, 06500
- Novartis Investigative Site
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Ankara, Pavo, 06490
- Novartis Investigative Site
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Warszawa, Polonia, 04-154
- Novartis Investigative Site
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San Juan, Puerto Rico, 00907
- Novartis Investigative Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
- Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
- Must be able to swallow minitablets (2mm in diameter) administered in soft food
- Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).
Exclusion Criteria:
- Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
- Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
- msSBP ≥ 25% above the 95th percentile
- Second or third degree heart block without a pacemaker
- AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
- Total bilirubin > 2 times the upper limit of the reference range
- Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]), based on the serum creatinine concentration obtained at the screening visit)
- WBC count < 3000/mm³
- Platelet count < 100,000/mm³
- Serum potassium > 5.2 mEq/L
- Other protocol-defined inclusion/exclusion criteria may apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Aliskiren
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
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Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg |
Comparador activo: Enalapril
Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
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Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study
Periodo de tiempo: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
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Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit.
The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
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Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Periodo de tiempo: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
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Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit.
The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
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Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
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Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study
Periodo de tiempo: Baseline to end of study (Week 52 or LOCF)
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MAP was defined as the average arterial pressure during a single cardiac cycle.
The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e.
MAP = DBP+1/3*(SBP--DBP).
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Baseline to end of study (Week 52 or LOCF)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CSPP100A2365E1
- 2009-017029-20 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Aliskiren
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NovartisTerminadoHipertensión esencialAlemania, España, Estados Unidos
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NovartisTerminado
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NovartisTerminado
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NovartisTerminadoHipertensiónEstonia, Francia, Islandia, India, Italia, Corea, república de, Lituania, España, Venezuela
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Chulalongkorn UniversityDesconocidoInsuficiencia de la membrana peritonealTailandia
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NovartisTerminado
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NovartisTerminadoHipertensiónBrasil, Canadá, Ecuador, Alemania, Hungría, Corea, república de, Malasia, México, Panamá, Filipinas, Singapur, Eslovaquia, España, Pavo, Reino Unido, Venezuela
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NovartisTerminadoHipertensiónEstados Unidos, Argentina, Colombia, Francia, Alemania, India, España
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NovartisTerminadoEficacia y seguridad de Aliskiren en pacientes con hipertensión leve a moderada durante el ejercicioHipertensiónSingapur, Hungría, República Checa, Reino Unido
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Novartis PharmaceuticalsTerminadoInsuficiencia cardiacaFederación Rusa, Alemania, Polonia