Trial · NCT00796510
Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
NCT00796510, Phase 3, Terminated, Pfizer; results first posted 2012-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety. Trials, record NCT00796510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00796510
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
- NCT number
- NCT00796510
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pulmonary Arterial Hypertension, Pulmonary Hypertension
- Interventions
- Sitaxsentan, Sitaxsentan and Sildenafil
- First posted
- 2008-11-24
- Last updated
- 2018-10-25
- Results first posted
- 2012-02-20
- Limitations and caveats
- Due to the premature termination only 3 participants were recruited into this study. No summarization or analysis was done.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Baseline and every 12 weeks up to Week 18 | Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up. |
| Secondary | Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24 | Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18) | The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline. |
| Secondary | Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH) | Baseline, Week 12 and ET (up to Week 18) | The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Baseline and every 12 weeks up to Week 18 | Due to the premature termination only 3 participants were recruited into this study. No analyses were performed. | ||
| SECONDARY | Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24 | Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18) | Due to the premature termination only 3 participants were recruited into this study. No analyses were performed. | ||
| SECONDARY | Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH) | Baseline, Week 12 and ET (up to Week 18) | Due to the premature termination only 3 participants were recruited into this study. No analyses were performed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitaxsentan | 3 | |
| Overall Study | STARTED | Sitaxsentan and Sildenafil | 0 | |
| Overall Study | COMPLETED | Sitaxsentan | 0 | |
| Overall Study | COMPLETED | Sitaxsentan and Sildenafil | 0 | |
| Overall Study | NOT COMPLETED | Sitaxsentan | 3 | |
| Overall Study | NOT COMPLETED | Sitaxsentan and Sildenafil | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | Non-cardiac chest pain | General disorders | Sitaxsentan | 1 | 3 | |
| other | Non-cardiac chest pain | General disorders | Sitaxsentan and Sildenafil | 0 | 0 | |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Sitaxsentan | 1 | 3 | |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Sitaxsentan and Sildenafil | 0 | 0 | |
| other | Pain in jaw | Musculoskeletal and connective tissue disorders | Sitaxsentan | 1 | 3 | |
| other | Pain in jaw | Musculoskeletal and connective tissue disorders | Sitaxsentan and Sildenafil | 0 | 0 | |
| serious | Cardiac arrest | Cardiac disorders | Sitaxsentan | 1 | 3 | |
| serious | Cardiac arrest | Cardiac disorders | Sitaxsentan and Sildenafil | 0 | 0 | |
| serious | Cytolytic hepatitis | Hepatobiliary disorders | Sitaxsentan | 1 | 3 | |
| serious | Cytolytic hepatitis | Hepatobiliary disorders | Sitaxsentan and Sildenafil | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitaxsentan | ||
| Total, all-cause mortality | Sitaxsentan and Sildenafil | ||
| Total, other adverse events | Sitaxsentan | 1 | 3 |
| Total, other adverse events | Sitaxsentan and Sildenafil | 0 | 0 |
| Total, serious adverse events | Sitaxsentan | 1 | 3 |
| Total, serious adverse events | Sitaxsentan and Sildenafil | 0 | 0 |
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/NCT00796510
GET https://conductscience.org/api/trials/v1/NCT00796510/registered