Trial · NCT01445873
Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
NCT01445873, Completed, Pfizer; results first posted 2012-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH). Trials, record NCT01445873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01445873
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT01445873
- Status
- Completed
- Enrollment
- 36 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Sitaxentan sodium
- First posted
- 2011-10-04
- Last updated
- 2020-09-01
- Results first posted
- 2012-06-08
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation | Sitaxentan (Thelin) | 2.2 | Standard Deviation 1.2 | months | |
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching | Sitaxentan (Thelin) | 0 | participants | ||
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation | Sitaxentan (Thelin) | 0 | participants | ||
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration | Sitaxentan (Thelin) | 6 | Standard Deviation 0 | months | |
| Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage | Sitaxentan (Thelin) | 100.0 | 95% Confidence Interval 100.0 to 100.0 | mg | |
| Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Sitaxentan (Thelin) | Anticoagulants | 83.3 | percentage of participants | |
| Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Sitaxentan (Thelin) | Diuretics | 88.9 | percentage of participants | |
| Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Sitaxentan (Thelin) | Calcium channel blockers | 22.2 | percentage of participants | |
| Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Sitaxentan (Thelin) | Digoxin | 5.6 | percentage of participants | |
| Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications | Sitaxentan (Thelin) | Supplemental oxygen | 44.4 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitaxentan (Thelin) | 36 | |
| Overall Study | COMPLETED | Sitaxentan (Thelin) | 36 | |
| Overall Study | NOT COMPLETED | Sitaxentan (Thelin) | 0 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Sitaxentan (Thelin) | 3 | 36 | |
| other | Peripheral edema | General disorders | Sitaxentan (Thelin) | 15 | 36 | |
| other | Nausea | General disorders | Sitaxentan (Thelin) | 3 | 36 | |
| other | Dizziness | General disorders | Sitaxentan (Thelin) | 12 | 36 | |
| other | Nasal congestion | General disorders | Sitaxentan (Thelin) | 0 | 36 | |
| other | Bleeding | General disorders | Sitaxentan (Thelin) | 5 | 36 | |
| other | Other events | General disorders | Sitaxentan (Thelin) | 21 | 36 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitaxentan (Thelin) | ||
| Total, other adverse events | Sitaxentan (Thelin) | 27 | 36 |
| Total, serious adverse events | Sitaxentan (Thelin) | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01445873
GET https://conductscience.org/api/trials/v1/NCT01445873/registered?page=2