Trial · NCT00795639

Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

NCT00795639, Phase 3, Terminated, Pfizer; results first posted 2012-03-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS). Trials, record NCT00795639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00795639

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
NCT number: NCT00795639
Status: Terminated
Phases: Phase 3
Enrollment: 183 participants, actual
Lead sponsor: Pfizer
Conditions: Pulmonary Arterial Hypertension, Pulmonary Hypertension
Interventions: Sitaxsentan, Placebo
First posted: 2008-11-21
Last updated: 2015-03-24
Results first posted: 2012-03-01
Limitations and caveats: Study terminated early.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12	Baseline/Day 1 and Week 12	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 is Week 12 results minus baseline results.
Secondary	Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	Baseline, Weeks 4, 8 and 12 or Early Termination (ET)	WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Improvement = reduction in functional class, deterioration = increase in functional class, no change = no change in functional class.
Secondary	Time to Clinical Worsening (TTCW)	Baseline, Weeks 4, 8 and 12 or ET	TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events included: hospitalization for worsening PAH, on-study death, heart-lung or lung transplant, atrial septostomy or withdrawal due to the addition of any chronic medications for the treatment of worsening PAH.

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	Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12	Baseline/Day 1 and Week 12	Intent to treat population (ITT): all participants who were randomized; missing value at Week 12 imputed with last non-missing value, including the non-missing value obtained at early termination based on last observation carried forward (LOCF)	Meters (m)	MEDIAN
SECONDARY	Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	Baseline, Weeks 4, 8 and 12 or Early Termination (ET)	ITT; N=number of participants with analyzable data; n=number of participants with analyzable data at the specific time point	participants	NUMBER
SECONDARY	Time to Clinical Worsening (TTCW)	Baseline, Weeks 4, 8 and 12 or ET	ITT; N=number of participants with analyzable data	days	MEDIAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12	Sitaxsentan	Baseline	343.0	Full Range 160 to 442	Meters (m)
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12	Placebo	Baseline	330.5	Full Range 169 to 456	Meters (m)
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12	Sitaxsentan	Change at Week 12	13.0	Full Range -349 to 105	Meters (m)
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12	Placebo	Change at Week 12	3.0	Full Range -338 to 104	Meters (m)
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	Sitaxsentan	Week 4 - Improvement (n=90, 87)	6		participants
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	Placebo	Week 4 - Improvement (n=90, 87)	2		participants
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	Sitaxsentan	Week 4 - No Change (n=90, 87)	83		participants
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	Placebo	Week 4 - No Change (n=90, 87)	84		participants
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	Sitaxsentan	Week 4 - Deterioration (n=90, 87)	1		participants
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	Placebo	Week 4 - Deterioration (n=90, 87)	1		participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sitaxsentan	91
Overall Study	STARTED	Placebo	92
Overall Study	Randomized and Not Treated	Sitaxsentan	0
Overall Study	Randomized and Not Treated	Placebo	1
Overall Study	COMPLETED	Sitaxsentan	70
Overall Study	COMPLETED	Placebo	66
Overall Study	NOT COMPLETED	Sitaxsentan	21
Overall Study	NOT COMPLETED	Placebo	26

Source ClinicalTrials.gov

Adverse events86

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
other	Vomiting	Gastrointestinal disorders	Sitaxsentan	2	91
other	Vomiting	Gastrointestinal disorders	Placebo	5	91
other	Chest pain	General disorders	Sitaxsentan	2	91
other	Chest pain	General disorders	Placebo	3	91
other	Fatigue	General disorders	Sitaxsentan	1	91
other	Fatigue	General disorders	Placebo	4	91
other	Oedema	General disorders	Sitaxsentan	3	91
other	Oedema	General disorders	Placebo	2	91
other	Oedema peripheral	General disorders	Sitaxsentan	5	91
other	Oedema peripheral	General disorders	Placebo	8	91

1 to 10 of 86Source ClinicalTrials.gov

See all 86 adverse events

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	Placebo
Total, other adverse events	Sitaxsentan	23	91
Total, other adverse events	Placebo	24	91
Total, serious adverse events	Sitaxsentan	9	91
Total, serious adverse events	Placebo	12	91

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 vs Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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