- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00255528
Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects (307A)
19 de marzo de 2007 actualizado por: AstraZeneca
Dose Ranging, Safety and Tolerability of TOPROL-XL® (Metoprolol Succinate) Extended-Release Tablets (Metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study
This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group study to determine the antihypertensive dose range, efficacy, safety and tolerability of TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects.
The study population included school age children (age 6 to < Tanner Stage 3) and adolescents (> Tanner Stage 3 to age 16) of both genders.
No more than 50% of the randomized subjects could be adolescents (> Tanner Stage 3 to 16 years old).
Since response to some therapies in adult hypertension appears to be different in black and non-black populations, recruitment was aimed at a mixture of black and non-black children.
The design included a 1-week screening period (for treatment naive subjects), a 1-week single-blind placebo run-in period, and a 4-week double-blind treatment period.
Eligible subjects were randomized to the double-blind period with a once daily oral dose of metoprolol CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo.
Dosing was weight adjusted.
The dose range for this study was 12.5 to 200 mg daily.
Subjects were closely monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment period.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción
144
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arkansas
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Little Rock, Arkansas, Estados Unidos
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California
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Bellflower, California, Estados Unidos
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Beverly Hills, California, Estados Unidos
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Los Angeles, California, Estados Unidos
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Orange, California, Estados Unidos
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Connecticut
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Hartford, Connecticut, Estados Unidos
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Delaware
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Wilmington, Delaware, Estados Unidos
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Florida
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Gainsville, Florida, Estados Unidos
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Miami, Florida, Estados Unidos
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Orlando, Florida, Estados Unidos
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Tampa, Florida, Estados Unidos
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Hawaii
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Honolulu, Hawaii, Estados Unidos
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Illinois
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Chicago, Illinois, Estados Unidos
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Kentucky
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Louisville, Kentucky, Estados Unidos
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New Jersey
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Livingston, New Jersey, Estados Unidos
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New York
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Bronx, New York, Estados Unidos
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New Hyde Park, New York, Estados Unidos
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North Carolina
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Durham, North Carolina, Estados Unidos
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Winston-Salem, North Carolina, Estados Unidos
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Ohio
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Cincinnati, Ohio, Estados Unidos
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Cleveland, Ohio, Estados Unidos
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Columbus, Ohio, Estados Unidos
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Pennsylvania
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Landsdale, Pennsylvania, Estados Unidos
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Philadelphia, Pennsylvania, Estados Unidos
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South Carolina
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Greenville, South Carolina, Estados Unidos
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Texas
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Beaumont, Texas, Estados Unidos
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Houston, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos
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Utah
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Salt Lake City, Utah, Estados Unidos
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Virginia
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Norfolk, Virginia, Estados Unidos
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Santo Domingo, República Dominicana
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años a 16 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or female between the ages of 6 and 16 years inclusive at the time of screening.
- Have a negative urine pregnancy test, if female of childbearing potential.
- Have a signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).
Have hypertension that is either:
- Newly diagnosed and untreated with a mean sitting SBP or DBP above the 95 th percentile on three consecutive office visits, or
- Previously diagnosed and currently treated with antihypertensive therapy at Visit 1, then at Visit 3 (off treatment) have a mean sitting SBP or DBP above the 95 th percentile.
- Have the ability to swallow tablets.
Exclusion Criteria:
- Have secondary hypertension due to coarctation of aorta, pheochromocytoma, hyperthyroidism or Cushing's syndrome.
- Have SBP or DBP greater than 20 (SBP) or 10 (DBP) mm Hg above the 95th percentile using height adjusted charts for age and gender.
- Have a heart rate < 55 beats per minute at randomization.
- Have a history of asthma and/or recurring pulmonary disease or infections.
- Have a history of cystic fibrosis.
- Have a known hypersensitivity reaction to beta-blockers.
- Have a known bleeding, coagulation or platelet disorder that can interfere with blood sampling.
- Have a history of Insulin Dependent Diabetes Mellitus.
- Be in any situation or have any condition which, in the opinion of the investigator or sponsor, may interfere with participation in the study or produce a significant risk to the subject or interfere with the assessment of safety and efficacy endpoints.
- Have received any investigational agent for any therapeutic reason within 30 days prior to receiving study medication.
- Have a clinically significant cardiac valvular disease.
- Have a diagnosis of heart failure.
- Have clinically significant arrhythmia. This is defined as any arrhythmia requiring medical therapy or that causes symptoms.
- Atrioventricular (AV) conduction disturbance, ie, second or third degree AV block.
- Be unable or unwilling to comply with the study requirements.
- Be non-compliant during the single-blind placebo run-in period of the study as defined by missing three or more doses between study visits.
- Have impaired liver function defined as either acute liver disease or chronic liver disease with persistent liver enzyme values greater than one and one half times the upper limit of the normal range for AST or ALT.
- Have a known history of bilateral renal artery stenosis, or unilateral renal artery stenosis to a single kidney. Nephrotic subjects who are not in remission should be excluded.
- Be pregnant or breast-feeding an infant.
- Currently taking medications known to inhibit CYP2D6, such as quinidine, fluoxetine, paroxetine and propafenone.
- Currently taking catecholamine-depleting medications such as reserpine. For any subject who is currently taking medications known to inhibit CYP2D6 or any catecholamine-depleting medication, the sponsor must be contacted to assess feasibility for inclusion into the study.
- Currently taking any selective serotonin re-uptake inhibitors (SSRIs) or atypical antipsychotic medication.
- Have a history of alcohol or drug abuse, or have a positive urine screen for drugs of abuse or alcohol.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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To evaluate the dose range, safety, and tolerability of metoprolol CR/XL in hypertensive pediatric subjects, based on the change in sitting SBP from baseline to the end of treatment.
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Medidas de resultado secundarias
Medida de resultado |
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Perfil de seguridad
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Slope of placebo-corrected changes in sitting DBP: baseline to end of treatment as a function of target dose. Differences in mean change: baseline to end of treatment comparing each active group to placebo for sitting SBP and DBP.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2002
Fechas de registro del estudio
Enviado por primera vez
17 de noviembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
17 de noviembre de 2005
Publicado por primera vez (Estimar)
21 de noviembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de marzo de 2007
Última actualización enviada que cumplió con los criterios de control de calidad
19 de marzo de 2007
Última verificación
1 de marzo de 2007
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Hipertensión
- Efectos fisiológicos de las drogas
- Beta-antagonistas adrenérgicos
- Antagonistas adrenérgicos
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes antiarrítmicos
- Agentes antihipertensivos
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Simpatolíticos
- Antagonistas del receptor beta-1 adrenérgico
- Metoprolol
Otros números de identificación del estudio
- D4020C00033
- 307A
- SH-MET-0033
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. .
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