Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
18 de agosto de 2020 atualizado 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.
Visão geral do estudo
Status
Status
Concluído
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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 estudo
Tipo de estudo
Observacional
Inscrição (Real)
Inscrição
36
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Número de grupos/coortes
1
Coortes e Intervenções
Grupo / CoorteGrupo / Coorte |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
PAH patients receiving Sitaxentan
|
Sitaxentan sodium 100 mg / day
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
Prazo: 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
Prazo: 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
Prazo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Mean Pulmonary Artery Pressure
Prazo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure
Prazo: 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
Prazo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Pulmonary Vascular Resistance
Prazo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Cardiac Output
Prazo: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Tei Index
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Day 1 to Month 6
|
Number of participants who died during the follow-up period.
|
Day 1 to Month 6
|
|
Number of Hospitalizations
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
1 de dezembro de 2009
Conclusão Primária (Real)
Conclusão Primária
28 de março de 2011
Conclusão do estudo (Real)
Conclusão do estudo
28 de março de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
30 de setembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de setembro de 2011
Primeira postagem (Estimativa)
Primeira postagem
4 de outubro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
1 de setembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de agosto de 2020
Última verificação
Última verificação
1 de agosto de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- B1321051
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .