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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.
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAH patients receiving Sitaxentan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitaxentan sodium | Drug | Sitaxentan sodium 100 mg / day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation | 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 | 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 | 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 | 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 | 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 | Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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Patterns of treatment with Thelin including duration and daily dosages reflect treament participants received in clinical practice. Treatment was not specified by the protocol.
Data for this retrospective non-interventional study were abtracted from the medical records of subjects who met study entry criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitaxentan (Thelin) | Duration and dose as prescribed in clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitaxentan (Thelin) | Duration and dose as prescribed in clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation | 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. | Full analysis set (FAS): participants with idiopathic pulmonary arterial hypertension (PAH) or PAH secondary to connective tissue disease, receipt of Thelin for treatment of PAH, 6 months of follow-up (except for death) after initial receipt (IR) of Thelin, and at least 1 clinic visit in medical record during 6-month period after IR of Thelin. | Posted | Mean | Standard Deviation | months | Day 1 to Month 6 |
|
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Pre-specified AEs of interest reported in medical records. Other events = emergency hospital admission, worsening PAH, unexplained anemia, alopecia, diarrhea, fatigue, obstipation, loss of appetite, gastric pain, numerous defecation, INH out of range, cardial decompensation, joint pain, pre-syncope, infection of IV line with need of explanation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitaxentan (Thelin) | Duration and dose as prescribed in clinical practice. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Pre-specified events | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Day 1 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 | Difference between pre-index and follow-up value. | Baseline to Month 6 |
| Change From Baseline in Mean Pulmonary Artery Pressure | Difference between pre-index and follow-up value. | Baseline to Month 6 |
| Change From Baseline in Pulmonary Capillary Wedge Pressure | Difference between pre-index and follow-up value. | Baseline to Month 6 |
| Change From Baseline in Left Ventricular End Diastolic Pressure | Difference between pre-index and follow-up value. | Baseline to Month 6 |
| Change From Baseline in Pulmonary Vascular Resistance | Difference between pre-index and follow-up value. | Baseline to Month 6 |
| Change From Baseline in Cardiac Output | Difference between pre-index and follow-up value. | Baseline to Month 6 |
| Change From Baseline in Tei Index | 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 | 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) | 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 | 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 | Difference between pre-index and follow-up value. | Baseline to Month 6 |
| Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening | 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 | Number of participants who died during the follow-up period. | Day 1 to Month 6 |
| Number of Hospitalizations | 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 | 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 | 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 | Number of participants who received an atrial septostomy (balloon or blade) during hospitalization. | Day 1 to Month 6 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching | Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period. | FAS | Posted | Number | participants | Day 1 to Month 6 |
|
|
|
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation | Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated. | FAS | Posted | Number | participants | Day 1 to Month 6 |
|
|
|
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration | Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy. | FAS; participants without evidence of discontinuation of Thelin therapy were censored at the end of follow-up (at 6 months or death if prior to 6 months). | Posted | Mean | Standard Deviation | months | Day 1 to Month 6 |
|
|
|
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed | Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first. | Not analyzed: duration of Thelin therapy as number of therapy days dispensed was not summarized; this measure was reported as duration in months only. | Posted | Day 1 to Month 6 |
|
|
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage | Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits. | FAS | Posted | Mean | 95% Confidence Interval | mg | Day 1 to Month 6 |
|
|
|
| Secondary | Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Use of PAH-related medications other than Thelin described by class of agent received. | FAS | Posted | Number | percentage of participants | Day 1 to Month 6 |
|
|
|
| Secondary | Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension | 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. | FAS; N=number of participants with pre-index (prior to Thelin initiation) and ≥ 1 WHO value recorded during follow-up. | Posted | Number | participants | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in Mean Right Atrial Pressure | Difference between pre-index and follow-up value. | FAS; N=number of participants with pre-index and ≥ 1 value recorded during follow-up period. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in Mean Pulmonary Artery Pressure | Difference between pre-index and follow-up value. | Data not analyzed: no participants had pre-index and follow-up values reported for this outcome measure. | Posted | Baseline to Month 6 |
|
|
| Secondary | Change From Baseline in Pulmonary Capillary Wedge Pressure | Difference between pre-index and follow-up value. | FAS; N=number of participants with pre-index and follow-up values. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in Left Ventricular End Diastolic Pressure | Difference between pre-index and follow-up value. | Data not analyzed: no participants had pre-index and follow-up values for this outcome measure. | Posted | Baseline to Month 6 |
|
|
| Secondary | Change From Baseline in Pulmonary Vascular Resistance | Difference between pre-index and follow-up value. | FAS; N=number of participants with pre-index and follow-up value. | Posted | Mean | 95% Confidence Interval | Dyn/s/cm5 | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in Cardiac Output | Difference between pre-index and follow-up value. | FAS; N=number of participants with pre-index and follow-up value. | Posted | Mean | 95% Confidence Interval | L/min | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in Tei Index | 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. | FAS; N=number of participants with pre-index and ≥ 1 follow-up value. | Posted | Mean | 95% Confidence Interval | ratio | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in Tricuspid Regurgitant Velocity | Difference between pre-index and follow-up value. | FAS; N=number of participants with pre-index and ≥ 1 follow-up value. | Posted | Mean | 95% Confidence Interval | m/sec | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) | 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. | FAS; N=number of participants with pre-index and 1 value recorded during follow-up period. | Posted | Mean | 95% Confidence Interval | meters | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in Borg Dyspnoea Score | 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. | FAS; N=number of participants with ≥ 1 value recorded during follow-up period. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Month 6 |
|
|
|
| Secondary | Change From Baseline in Percent of Predicted Peak VO2 | Difference between pre-index and follow-up value. | FAS; N=number of participants with ≥ 1 value recorded during follow-up period. | Posted | Mean | 95% Confidence Interval | percent Vo2 | Baseline to Month 6 |
|
|
|
| Secondary | Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening | 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. | FAS | Posted | Mean | Standard Deviation | months | Day 1 to Month 6 |
|
|
|
| Secondary | Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality | Number of participants who died during the follow-up period. | FAS | Posted | Number | participants | Day 1 to Month 6 |
|
|
|
| Secondary | Number of Hospitalizations | All hospitalizations during the follow-up period recorded in medical records. | FAS | Posted | Mean | 95% Confidence Interval | hospitalizations | Day 1 to Month 6 |
|
|
|
| Secondary | Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation | Number of participants who received an lung transplant during hospitalization. | FAS; N=number of participants with hospitalizations during follow-up period. | Posted | Number | participants | Day 1 to Month 6 |
|
|
|
| Secondary | Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation | Number of participants who received an heart/lung transplant during hospitalization. | FAS; N=number of participants with hospitalizations during follow-up period. | Posted | Number | participants | Day 1 to Month 6 |
|
|
|
| Secondary | Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy | Number of participants who received an atrial septostomy (balloon or blade) during hospitalization. | FAS; N=number of participants with hospitalizations during follow-up period. | Posted | Number | participants | Day 1 to Month 6 |
|
|
|
| 0 |
| 36 |
| 27 |
| 36 |
| Peripheral edema | General disorders | Pre-specified events | Systematic Assessment |
|
| Nausea | General disorders | Pre-specified events | Systematic Assessment |
|
| Dizziness | General disorders | Pre-specified events | Systematic Assessment |
|
| Nasal congestion | General disorders | Pre-specified events | Systematic Assessment |
|
| Bleeding | General disorders | Pre-specified events | Systematic Assessment |
|
| Other events | General disorders | Pre-specified events | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Digoxin |
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| Supplemental oxygen |
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| Prostanoids |
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| Other endothelin receptor antagonists |
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| Phosphodiesterase-5 inhibitors |
|
| Title | Measurements |
|---|---|
|
| Pre-index functional class (FC) I to FC IV |
|
| Pre-index functional class (FC) II to FC I |
|
| Pre-index functional class (FC) II to FC II |
|
| Pre-index functional class (FC) II to FC III |
|
| Pre-index functional class (FC) II to FC IV |
|
| Pre-index functional class (FC) III to FC I |
|
| Pre-index functional class (FC) III to FC II |
|
| Pre-index functional class (FC) III to FC III |
|
| Pre-index functional class (FC) III to FC IV |
|
| Pre-index functional class (FC) IV to FC I |
|
| Pre-index functional class (FC) IV to FC II |
|
| Pre-index functional class (FC) IV to FC III |
|
| Pre-index functional class (FC) IV to FC IV |
|