Trial · NCT01445873
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation | Day 1 to Month 6 | 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. | months | MEAN |
| PRIMARY | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching | Day 1 to Month 6 | FAS | participants | NUMBER |
| PRIMARY | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation | Day 1 to Month 6 | FAS | participants | NUMBER |
| PRIMARY | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration | Day 1 to Month 6 | 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). | months | MEAN |
| PRIMARY | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed | Day 1 to Month 6 | Not analyzed: duration of Thelin therapy as number of therapy days dispensed was not summarized; this measure was reported as duration in months only. | ||
| PRIMARY | Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage | Day 1 to Month 6 | FAS | mg | MEAN |
| SECONDARY | Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Day 1 to Month 6 | FAS | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension | Baseline to Month 6 | FAS; N=number of participants with pre-index (prior to Thelin initiation) and ≥ 1 WHO value recorded during follow-up. | participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Right Atrial Pressure | Baseline to Month 6 | FAS; N=number of participants with pre-index and ≥ 1 value recorded during follow-up period. | mm Hg | MEAN |
| SECONDARY | Change From Baseline in Mean Pulmonary Artery Pressure | Baseline to Month 6 | Data not analyzed: no participants had pre-index and follow-up values reported for this outcome measure. | ||
| SECONDARY | Change From Baseline in Pulmonary Capillary Wedge Pressure | Baseline to Month 6 | FAS; N=number of participants with pre-index and follow-up values. | mm Hg | MEAN |
| SECONDARY | Change From Baseline in Left Ventricular End Diastolic Pressure | Baseline to Month 6 | Data not analyzed: no participants had pre-index and follow-up values for this outcome measure. | ||
| SECONDARY | Change From Baseline in Pulmonary Vascular Resistance | Baseline to Month 6 | FAS; N=number of participants with pre-index and follow-up value. | Dyn/s/cm5 | MEAN |
| SECONDARY | Change From Baseline in Cardiac Output | Baseline to Month 6 | FAS; N=number of participants with pre-index and follow-up value. | L/min | MEAN |
| SECONDARY | Change From Baseline in Tei Index | Baseline to Month 6 | FAS; N=number of participants with pre-index and ≥ 1 follow-up value. | ratio | MEAN |
| SECONDARY | Change From Baseline in Tricuspid Regurgitant Velocity | Baseline to Month 6 | FAS; N=number of participants with pre-index and ≥ 1 follow-up value. | m/sec | MEAN |
| SECONDARY | Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) | Baseline to Month 6 | FAS; N=number of participants with pre-index and 1 value recorded during follow-up period. | meters | MEAN |
| SECONDARY | Change From Baseline in Borg Dyspnoea Score | Baseline to Month 6 | FAS; N=number of participants with ≥ 1 value recorded during follow-up period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Percent of Predicted Peak VO2 | Baseline to Month 6 | FAS; N=number of participants with ≥ 1 value recorded during follow-up period. | percent Vo2 | MEAN |
| SECONDARY | Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening | Day 1 to Month 6 | FAS | months | MEAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01445873/outcomes