Trial · NCT01210443
Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
NCT01210443, Phase 3, Terminated, Pfizer; results first posted 2011-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients. Trials, record NCT01210443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01210443
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
- NCT number
- NCT01210443
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hypertension, Pulmonary
- Interventions
- Sitaxentan
- First posted
- 2010-09-28
- Last updated
- 2011-12-14
- Results first posted
- 2011-12-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Up to 22 days (last participant discontinuation) | Number of participants with any adverse events, severe adverse events, serious adverse events |
| Secondary | Percentage of Participants With Clinical Worsening | Up to 22 days (last participant discontinuation) | Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen. |
| Secondary | Change From Baseline in 6-Minute Walk Distance | Up to 22 days (last participant discontinuation) | Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline. |
| Secondary | Percentage of Participants With Change From Baseline in WHO Functional Class | Up to 22 days (last participant discontinuation) | The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48). |
| Secondary | Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | Up to 22 days (last participant discontinuation) | Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | Up to 22 days (last participant discontinuation) | The safety analysis set is defined as all subjects who receive at least one dose of study drug during this extension study. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Worsening | Up to 22 days (last participant discontinuation) | The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 6-Minute Walk Distance | Up to 22 days (last participant discontinuation) | The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants. | Meters | MEAN |
| SECONDARY | Percentage of Participants With Change From Baseline in WHO Functional Class | Up to 22 days (last participant discontinuation) | The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants. | Parcentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | Up to 22 days (last participant discontinuation) | The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants. | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Sitaxentan Treatment | Treatment emergent all-causality adverse events | 1 | Participants | |
| Number of Participants With Adverse Events | Sitaxentan Treatment | Treatment emergen-causality serious adverse events | 0 | Participants | |
| Number of Participants With Adverse Events | Sitaxentan Treatment | Treatment emergent all-causality severe adverse ev | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitaxentan Treatment | 2 | |
| Overall Study | COMPLETED | Sitaxentan Treatment | 0 | |
| Overall Study | NOT COMPLETED | Sitaxentan Treatment | 2 |
Source ClinicalTrials.gov
Adverse events2
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 | Diarrhoea | Gastrointestinal disorders | Sitaxentan Treatment | 1 | 2 | |
| other | Headache | Nervous system disorders | Sitaxentan Treatment | 1 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitaxentan Treatment | ||
| Total, other adverse events | Sitaxentan Treatment | 1 | 2 |
| Total, serious adverse events | Sitaxentan Treatment | 0 | 2 |
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/NCT01210443
GET https://conductscience.org/api/trials/v1/NCT01210443/registered