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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 36
- 主要终点
- Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed
研究概览
简要总结
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.
详细描述
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
PAH patients receiving Sitaxentan
干预措施: Sitaxentan sodium (Drug)
结局指标
主要结局
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed
时间窗: 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.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
时间窗: 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.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching
时间窗: 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.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage
时间窗: 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.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation
时间窗: 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.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration
时间窗: 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.
次要结局
- Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications(Day 1 to Month 6)
- Change From Baseline in Mean Right Atrial Pressure(Baseline to Month 6)
- Change From Baseline in Borg Dyspnoea Score(Baseline to Month 6)
- Change From Baseline in Percent of Predicted Peak VO2(Baseline to Month 6)
- Number of Hospitalizations(Day 1 to Month 6)
- Change From Baseline in Mean Pulmonary Artery Pressure(Baseline to Month 6)
- Change From Baseline in Pulmonary Vascular Resistance(Baseline to Month 6)
- Change From Baseline in Tricuspid Regurgitant Velocity(Baseline to Month 6)
- Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy(Day 1 to Month 6)
- Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension(Baseline to Month 6)
- Change From Baseline in Pulmonary Capillary Wedge Pressure(Baseline to Month 6)
- Change From Baseline in Tei Index(Baseline to Month 6)
- Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality(Day 1 to Month 6)
- Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation(Day 1 to Month 6)
- Change From Baseline in Left Ventricular End Diastolic Pressure(Baseline to Month 6)
- Change From Baseline in Cardiac Output(Baseline to Month 6)
- Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)(Baseline to Month 6)
- Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening(Day 1 to Month 6)
- Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation(Day 1 to Month 6)