Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
18 de agosto de 2020 actualizado por: Pfizer
NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings; to pilot test these methods at three study centers in Europe; and to refine and finalize research methods and corresponding materials for possible use in a follow-on, full-scale examination of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Actual)
Inscripción
36
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
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with Pulmonary Arterial Hypertension (PAH) (Idiopathic or secondary to connective tissue disease), receiving sitaxentan sodium (Thelin) for treatment of their PAH for at least 6 months.
Descripción
Inclusion Criteria:
- Idiopathic PAH, or PAH secondary to connective tissue disease
- Receipt of Thelin for treatment of PAH
- 6 months of follow-up (except in the event of death) subsequent to initial receipt of Thelin
- Minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of Thelin
Exclusion Criteria:
- Participation in any investigational study of Thelin or any other medication for the treatment of PAH during the period beginning 6 months prior to initial receipt of Thelin and ending 6 months subsequent to such receipt
- Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2, and/or STRIDE-6); or
- Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment [Child-Pugh Class A-C]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times upper limit of normal [ULN]; concomitant use of cyclosporin A; lactation)
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
Número de grupos/cohortes
1
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
PAH patients receiving Sitaxentan
|
Sitaxentan sodium 100 mg / day
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
Periodo de tiempo: Day 1 to Month 6
|
Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg.
bosentan, sildenafil) not previously received during the study period.
Mean time in months to therapy augmentation.
|
Day 1 to Month 6
|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching
Periodo de tiempo: Day 1 to Month 6
|
Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.
|
Day 1 to Month 6
|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation
Periodo de tiempo: Day 1 to Month 6
|
Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.
|
Day 1 to Month 6
|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration
Periodo de tiempo: Day 1 to Month 6
|
Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.
|
Day 1 to Month 6
|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed
Periodo de tiempo: Day 1 to Month 6
|
Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.
|
Day 1 to Month 6
|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage
Periodo de tiempo: Day 1 to Month 6
|
Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.
|
Day 1 to Month 6
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
Periodo de tiempo: Day 1 to Month 6
|
Use of PAH-related medications other than Thelin described by class of agent received.
|
Day 1 to Month 6
|
|
Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension
Periodo de tiempo: Baseline to Month 6
|
Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but < ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA.
|
Baseline to Month 6
|
|
Change From Baseline in Mean Right Atrial Pressure
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Mean Pulmonary Artery Pressure
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Left Ventricular End Diastolic Pressure
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Pulmonary Vascular Resistance
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Cardiac Output
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Tei Index
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
Combined myocardial performance index calculated by adding isovolumic contraction time and isovolumic relaxation time and dividing the resulting sum by ejection time.
|
Baseline to Month 6
|
|
Change From Baseline in Tricuspid Regurgitant Velocity
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)
Periodo de tiempo: Baseline to Month 6
|
6MWT was the distance that a participant could walk in 6 minutes.
Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Continuous pulse oximetry was conducted during the test for safety.
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Borg Dyspnoea Score
Periodo de tiempo: Baseline to Month 6
|
Borg dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum).
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Percent of Predicted Peak VO2
Periodo de tiempo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening
Periodo de tiempo: Day 1 to Month 6
|
Occurrence of any of the following: death, unplanned PAH-related hospitalization, initiation of epoprostenol, arterial septostomy, lung or heart/lung transplantation, ≥15% decrease from baseline in 6 minute walk test, signs/symptoms of right sided heart failure, and/or worsening WHO functional class.
|
Day 1 to Month 6
|
|
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality
Periodo de tiempo: Day 1 to Month 6
|
Number of participants who died during the follow-up period.
|
Day 1 to Month 6
|
|
Number of Hospitalizations
Periodo de tiempo: Day 1 to Month 6
|
All hospitalizations during the follow-up period recorded in medical records.
|
Day 1 to Month 6
|
|
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation
Periodo de tiempo: Day 1 to Month 6
|
Number of participants who received an lung transplant during hospitalization.
|
Day 1 to Month 6
|
|
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation
Periodo de tiempo: Day 1 to Month 6
|
Number of participants who received an heart/lung transplant during hospitalization.
|
Day 1 to Month 6
|
|
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy
Periodo de tiempo: Day 1 to Month 6
|
Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.
|
Day 1 to Month 6
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
Inicio del estudio
1 de diciembre de 2009
Finalización primaria (Actual)
Finalización primaria
28 de marzo de 2011
Finalización del estudio (Actual)
Finalización del estudio
28 de marzo de 2011
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
30 de septiembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
30 de septiembre de 2011
Publicado por primera vez (Estimar)
Publicado por primera vez
4 de octubre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
1 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
18 de agosto de 2020
Última verificación
Última verificación
1 de agosto de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Hipertensión Pulmonar
- Hipertensión
- Hipertensión arterial pulmonar
- Hipertensión pulmonar primaria familiar
- Mecanismos moleculares de acción farmacológica
- Antagonistas de los receptores de endotelina
- Sitaxsentán
Otros números de identificación del estudio
Otros números de identificación del estudio
- B1321051
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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. .