Trial · NCT00796666
Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil
NCT00796666, Phase 3, Terminated, Pfizer; results first posted 2012-02-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil. Trials, record NCT00796666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00796666
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil
- NCT number
- NCT00796666
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 131 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pulmonary Arterial Hypertension, Pulmonary Hypertension
- Interventions
- Sitaxsentan, Sitaxsentan and Sildenafil
- First posted
- 2008-11-24
- Last updated
- 2015-03-24
- Results first posted
- 2012-02-29
- Limitations and caveats
- Study terminated early by sponsor, no Week 48 information collected.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Clinical Worsening (TTCW) | Baseline, Weeks 12, 24 or Early Termination (ET) | Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study's first dose date in and date when first clinical worsening event occurs. |
| Secondary | Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) | Baseline to Weeks 12 and 24 | 6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change from baseline = score at Week x - score at baseline. |
| Secondary | Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48 | Baseline, Weeks 12, 24 or ET | WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X. |
| Secondary | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain | Baseline, Weeks 12, 24 and ET | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline. |
| Secondary | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain | Baseline, Weeks 12, 24 or ET | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline. |
| Secondary | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain | Baseline, Weeks 12, 24 or ET | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline. |
| Secondary | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain | Baseline, Weeks 12, 24 or ET | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline. |
| Secondary | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain | Baseline, Weeks 12, 24 or ET | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Vitality score at Week x minus score at baseline. |
| Secondary | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain | Baseline, Weeks 12, 24 or ET | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline. |
| Secondary | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain | Baseline, Weeks 12, 24 or ET | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Clinical Worsening (TTCW) | Baseline, Weeks 12, 24 or Early Termination (ET) | Intent-to-Treat population (ITT): all participants who were randomized | Days | MEDIAN |
| SECONDARY | Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) | Baseline to Weeks 12 and 24 | ITT; N=number of participants analyzed; Missing values at Weeks 12 and 24 imputed with the last non-missing 6MWD based on the last observation carried forward (LOCF) method | meters (m) | MEAN |
| SECONDARY | Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48 | Baseline, Weeks 12, 24 or ET | ITT | participant | NUMBER |
| SECONDARY | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain | Baseline, Weeks 12, 24 and ET | ITT; N=number of participants analyzed | units on a scale | MEAN |
| SECONDARY | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain | Baseline, Weeks 12, 24 or ET | ITT; N=number of participants analyzed | units on a scale | MEAN |
| SECONDARY | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain | Baseline, Weeks 12, 24 or ET | ITT; N=number of participants analyzed | units on a scale | MEAN |
| SECONDARY | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain | Baseline, Weeks 12, 24 or ET | ITT; N=number of participants analyzed | units on a scale | MEAN |
| SECONDARY | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain | Baseline, Weeks 12, 24 or ET | ITT; N=number of participants analyzed | units on a scale | MEAN |
| SECONDARY | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain | Baseline, Weeks 12, 24 or ET | ITT; N=number of participants analyzed | units on a scale | MEAN |
| SECONDARY | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain | Baseline, Weeks 12, 24 or ET | ITT; N=number of participants analyzed | units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Clinical Worsening (TTCW) | Sitaxsentan and Placebo | NA | Full Range 123 to 356 | Days | |
| Time to Clinical Worsening (TTCW) | Sitaxsentan and Sildenafil | NA | Full Range 119 to 409 | Days | |
| Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) | Sitaxsentan and Placebo | Baseline | 350.9 | Standard Deviation 74.47 | meters (m) |
| Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) | Sitaxsentan and Sildenafil | Baseline | 354.7 | Standard Deviation 79.88 | meters (m) |
| Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) | Sitaxsentan and Placebo | Change at Week 12 | -6.9 | Standard Deviation 71.00 | meters (m) |
| Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) | Sitaxsentan and Sildenafil | Change at Week 12 | 23.2 | Standard Deviation 56.49 | meters (m) |
| Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) | Sitaxsentan and Placebo | Change at Week 24 | -5.4 | Standard Deviation 62.74 | meters (m) |
| Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD) | Sitaxsentan and Sildenafil | Change at Week 24 | 17.5 | Standard Deviation 66.84 | meters (m) |
| Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48 | Sitaxsentan and Placebo | Week 12 Improvement | 14 | participant | |
| Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48 | Sitaxsentan and Sildenafil | Week 12 Improvement | 14 | participant |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitaxsentan and Placebo | 67 | |
| Overall Study | STARTED | Sitaxsentan and Sildenafil | 64 | |
| Overall Study | Treated | Sitaxsentan and Placebo | 66 | |
| Overall Study | Treated | Sitaxsentan and Sildenafil | 64 | |
| Overall Study | Randomized and Not Treated | Sitaxsentan and Placebo | 1 | |
| Overall Study | Randomized and Not Treated | Sitaxsentan and Sildenafil | 0 | |
| Overall Study | COMPLETED | Sitaxsentan and Placebo | 0 | |
| Overall Study | COMPLETED | Sitaxsentan and Sildenafil | 0 | |
| Overall Study | NOT COMPLETED | Sitaxsentan and Placebo | 67 | |
| Overall Study | NOT COMPLETED | Sitaxsentan and Sildenafil | 64 |
Source ClinicalTrials.gov
Adverse events172
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 | Anaemia | Blood and lymphatic system disorders | Sitaxsentan and Placebo | 2 | 66 | |
| other | Anaemia | Blood and lymphatic system disorders | Sitaxsentan and Sildenafil | 2 | 64 | |
| other | Cardiac failure congestive | Cardiac disorders | Sitaxsentan and Placebo | 2 | 66 | |
| other | Cardiac failure congestive | Cardiac disorders | Sitaxsentan and Sildenafil | 0 | 64 | |
| other | Abdominal pain | Gastrointestinal disorders | Sitaxsentan and Placebo | 0 | 66 | |
| other | Abdominal pain | Gastrointestinal disorders | Sitaxsentan and Sildenafil | 3 | 64 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Sitaxsentan and Placebo | 2 | 66 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Sitaxsentan and Sildenafil | 0 | 64 | |
| other | Haemorrhoids | Gastrointestinal disorders | Sitaxsentan and Placebo | 2 | 66 | |
| other | Haemorrhoids | Gastrointestinal disorders | Sitaxsentan and Sildenafil | 0 | 64 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitaxsentan and Placebo | ||
| Total, all-cause mortality | Sitaxsentan and Sildenafil | ||
| Total, other adverse events | Sitaxsentan and Placebo | 26 | 66 |
| Total, other adverse events | Sitaxsentan and Sildenafil | 28 | 64 |
| Total, serious adverse events | Sitaxsentan and Placebo | 14 | 66 |
| Total, serious adverse events | Sitaxsentan and Sildenafil | 15 | 64 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sitaxsentan and Placebo vs Sitaxsentan and Sildenafil: serious adverse events |
Source Trial comparisons
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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