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.
調査の概要
詳細な説明
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
研究の種類
観察的
入学 (実際)
36
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
PAH patients receiving Sitaxentan
|
Sitaxentan sodium 100 mg / day
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
時間枠：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
時間枠：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
時間枠：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Mean Pulmonary Artery Pressure
時間枠：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure
時間枠：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
時間枠：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Pulmonary Vascular Resistance
時間枠：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Cardiac Output
時間枠：Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
|
Change From Baseline in Tei Index
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 1 to Month 6
|
Number of participants who died during the follow-up period.
|
Day 1 to Month 6
|
|
Number of Hospitalizations
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 1 to Month 6
|
Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.
|
Day 1 to Month 6
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2009年12月1日
一次修了 (実際)
2011年3月28日
研究の完了 (実際)
2011年3月28日
試験登録日
最初に提出
2011年9月30日
QC基準を満たした最初の提出物
2011年9月30日
最初の投稿 (見積もり)
2011年10月4日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月1日
QC基準を満たした最後の更新が送信されました
2020年8月18日
最終確認日
2020年8月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- B1321051
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
肺動脈高血圧の臨床試験
-
University of Sao Paulo General Hospitalまだ募集していませんCOPD | 肺疾患および/または低酸素症に続発する肺高血圧症 | Pulmnary Hypertension