Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
2020年8月18日 更新者：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.
研究概览
详细说明
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
研究类型
观察性的
注册 (实际的)
36
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
PAH patients receiving Sitaxentan
|
Sitaxentan sodium 100 mg / day
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
大体时间：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
大体时间：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
大体时间：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Mean Pulmonary Artery Pressure
大体时间：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure
大体时间：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
大体时间：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Pulmonary Vascular Resistance
大体时间：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Cardiac Output
大体时间：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Tei Index
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Day 1 to Month 6
|
Number of participants who died during the follow-up period.
|
Day 1 to Month 6
|
|
Number of Hospitalizations
大体时间：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
大体时间：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
大体时间：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
大体时间：Day 1 to Month 6
|
Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.
|
Day 1 to Month 6
|
合作者和调查者
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出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2009年12月1日
初级完成 (实际的)
2011年3月28日
研究完成 (实际的)
2011年3月28日
研究注册日期
首次提交
2011年9月30日
首先提交符合 QC 标准的
2011年9月30日
首次发布 (估计)
2011年10月4日
研究记录更新
最后更新发布 (实际的)
2020年9月1日
上次提交的符合 QC 标准的更新
2020年8月18日
最后验证
2020年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- B1321051
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Sitaxentan sodium的临床试验
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