Trial · NCT01445873
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation | 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. |
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching | 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. |
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation | 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. |
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration | 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. |
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed | 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. |
| Primary | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage | 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. |
| Secondary | Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Day 1 to Month 6 | Use of PAH-related medications other than Thelin described by class of agent received. |
| Secondary | Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension | 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. |
| Secondary | Change From Baseline in Mean Right Atrial Pressure | Baseline to Month 6 | Difference between pre-index and follow-up value. |
| Secondary | Change From Baseline in Mean Pulmonary Artery Pressure | Baseline to Month 6 | Difference between pre-index and follow-up value. |
| Secondary | Change From Baseline in Pulmonary Capillary Wedge Pressure | Baseline to Month 6 | Difference between pre-index and follow-up value. |
| Secondary | Change From Baseline in Left Ventricular End Diastolic Pressure | Baseline to Month 6 | Difference between pre-index and follow-up value. |
| Secondary | Change From Baseline in Pulmonary Vascular Resistance | Baseline to Month 6 | Difference between pre-index and follow-up value. |
| Secondary | Change From Baseline in Cardiac Output | Baseline to Month 6 | Difference between pre-index and follow-up value. |
| Secondary | Change From Baseline in Tei Index | 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. |
| Secondary | Change From Baseline in Tricuspid Regurgitant Velocity | Baseline to Month 6 | Difference between pre-index and follow-up value. |
| Secondary | Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) | 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. |
| Secondary | Change From Baseline in Borg Dyspnoea Score | 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. |
| Secondary | Change From Baseline in Percent of Predicted Peak VO2 | Baseline to Month 6 | Difference between pre-index and follow-up value. |
| Secondary | Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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