Trial · NCT01204853
A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
NCT01204853, Phase 3, Terminated, Pfizer; results first posted 2011-12-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients. Trials, record NCT01204853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01204853
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
- NCT number
- NCT01204853
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hypertension, Pulmonary
- Interventions
- Sitaxentan
- First posted
- 2010-09-17
- Last updated
- 2011-12-01
- Results first posted
- 2011-12-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 12 weeks | Number of participants with any adverse events, severe adverse events, serious adverse events |
| Primary | Change From Baseline in 6-minute Walk Distance | 12 weeks | Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline. |
| Secondary | Change From Baseline in WHO Functional Class | 12 weeks | The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class at Week 12 was to be summarized with frequency count and percentage in each category based on imputed data for missing values at Week 12. |
| Secondary | Number of Participants With Haemodynamics Parameters | 12 weeks | The following haemodynamic measurements were assessed: right arterial pressure, pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, left ventricular-end diastolic pressure, cardiac output, systemic arterial blood pressure (systolic, diastolic and mean), and heart rate. Change from baseline in haemodynamics parameters is calculated as the value at Week 12 minus value at baseline. |
| Secondary | Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | 12 weeks | Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline. |
| Secondary | Clinical Worsening | 12 weeks | 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 | Number of Participants With Pharmacokinetic (PK) Parameters at Steady State | pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination | The following PK parameters at the steady state were evaluated: maximum observed concentration during the dosing interval (Cmax), time for maximum observed concentration during the dosing interval (Tmax), area under the plasma concentration-time curve over dosing interval tau for multiple dose (AUCtau), terminal elimination half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during the terminal elimination phase (Vz/F) at Week 12/Termination (as data permit), and concentration predose during multiple dosing (Ctrough) at Week 2, 4, 8 and 12/Termination. |
Source ClinicalTrials.gov
Outcomes7
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 | 12 weeks | Safety analysis set is defined as all participants who receive at least one dose of the study drug.~Descriptive statistics for adverse events were not calculated due to a small number of subjects. | Participant | NUMBER |
| PRIMARY | Change From Baseline in 6-minute Walk Distance | 12 weeks | Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in 6-minute walk distance were not calculated due to a small number of participants. | Meters | MEAN |
| SECONDARY | Change From Baseline in WHO Functional Class | 12 weeks | Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in WHO functional class were not calculated due to a small number of participants. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Haemodynamics Parameters | 12 weeks | Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in haemodynamics parameters were not calculated due to a small number of participants. | Participants | NUMBER |
| SECONDARY | Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | 12 weeks | Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in NT-pro BNP were not calculated due to a small number of participants. | pg/mL | MEAN |
| SECONDARY | Clinical Worsening | 12 weeks | Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for clinical worsening were not calculated due to a small number of participants. | Participants | NUMBER |
| SECONDARY | Number of Participants With Pharmacokinetic (PK) Parameters at Steady State | pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination | The PK concentration set was defined as all participants who have at least 1 concentration.~The PK parameter analysis set was defined as all participants who have at least 1 of PK parameters of interest.~Descriptive statistics for PK parameters were not calculated due to a small number of participants. | Participants | NUMBER |
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 | All-causality adverse events | 1 | Participant | |
| Number of Participants With Adverse Events | Sitaxentan Treatment | All-causality serious adverse events | 0 | Participant | |
| Number of Participants With Adverse Events | Sitaxentan Treatment | All-causality severe adverse events | 0 | Participant |
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 | 2 | |
| Overall Study | NOT COMPLETED | Sitaxentan Treatment | 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 | Abdominal pain | Gastrointestinal disorders | Sitaxentan Treatment | 1 | 2 | |
| other | Chest pain | General disorders | Sitaxentan Treatment | 1 | 2 | |
| other | Oedema | General disorders | Sitaxentan Treatment | 1 | 2 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Sitaxentan Treatment | 1 | 2 | |
| other | Dizziness | Nervous system disorders | Sitaxentan Treatment | 1 | 2 | |
| other | Headache | Nervous system disorders | Sitaxentan Treatment | 1 | 2 | |
| other | Panic attack | Psychiatric 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/NCT01204853
GET https://conductscience.org/api/trials/v1/NCT01204853/registered