Cardiac Surgery SubjectsPhase 2FCAD02NCT00838383

Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

A Phase 2 study testing sitaxsentan (Thelin) in people with Cardiac Surgery Subjects and Subjects Undergoing CABG and/or Cardiac Valve Replacement, run by Pfizer at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB. Read more about this study

Who is it for?: Ages 48 to 82 years
Conditions the study is for: Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
What is being tested?: sitaxsentan (Thelin)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 3 sitesUnited States
Study dates: 10 Aug 2006to 31 Mar 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 48 to 82 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has been identified for coronary artery bypass grafting (CABG), aortic and/or mitral valve replacement, or combined CABG and cardiac valve replacement procedures that require cardiopulmonary bypass (CPB).

Who cannot join

Requires an emergent or "emergency" CABG and/or cardiac valve replacement.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Medical University of South Carolina
Charleston, South Carolina, 29425
The Chattanooga Heart Institute
Chattanooga, Tennessee, 37404
University of Pennsylvania,
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: SELECTIVE ENDOTHELIN TYPE A RECEPTOR INHIBITION IN CARDIAC SURGERY SUBJECTS WITH PRE-EXISTING CARDIOVASCULAR RISK FACTORS: A DOSE CONFIRMATION STUDY

Conditions: Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
Being tested: sitaxsentan (Thelin), Placebo
Keywords: multi-center, placebo-controlled, randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sitaxsentan (Thelin)Drug
Also called sitaxsentan, Thelin
sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
sitaxsentan (Thelin)Drug
Also called sitaxsentan, Thelin
Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.
PlaceboDrug
Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.

Study groups in NCT00838383
Study group	Role	What they receive
sitaxsentan (1.0 mg/kg)	Experimental	Not described Receives: Drug: sitaxsentan (Thelin)
sitaxsentan (2.0 mg/kg)	Experimental	Not described Receives: Drug: sitaxsentan (Thelin)
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean pulmonary artery pressure (PAP) (millimeter of mercury [mmHg]), pulmonary capillary wedge pressure (PCWP [mmHg]) and cardiac output (CO [litres per minute]). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= stroke volume (SV)*heart rate (HR). Post-separation from CPB was the time immediately following cross-clamp release in CPB. Percent change in PVR at 0.5 hour post-separation from CPB in participants were summarized and reported.
Measured: 0 hour, 0.5 hour post-separation from CPB
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= SV * HR. Percent change in PVR at 6 hour in participants were summarized and reported.
Measured: 0 hour, 6 hour post-separation from CPB
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= SV * HR. Percent change in PVR at 12 hour in participants were summarized and reported.
Measured: 0 hour, 12 hour post-separation from CPB
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= SV * HR. Percent change in PVR at 24 hour in participants were summarized and reported.
Measured: 0 hour, 24 hour post-separation from CPB
Mortality: Number of Participants Died During Surgery and Initial Hospitalization
Number of participants who died during surgery or during initial hospitalization are reported here.
Measured: During surgery, initial hospitalization period (up to 29 days for 1 mg/kg group, up to 44 days for 2 mg/kg dose group, up to 19 days for placebo group)
Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation
Number of participants with following incidents: myocardial infarction (Q and non-Q wave); stroke or cerebrovascular event (acute ischemia, hemorrhagic stroke or infarction, or a transient ischemia attack); hemodynamic collapse (requiring ventricular assistance devices) and re-operation (participants who returned to the operating room) during the initial hospitalization were reported.
Measured: Initial hospitalization period (up to 44 days)

Secondary outcomes (16)

Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period
Participants were considered for inotropic requirements/therapy in case of either severe right ventricular failure or high pulmonary artery pressure, or if cardiac output was not maintained with epinephrine.
Measured: Immediately after cross-clamp removal up to 24 hours post-separation from CPB
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant.
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs).
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Heart rate was assessed as one of the hemodynamic profile assessments at the specified time points.
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. It was used to evaluate the hemodynamic profile of each participant.
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. It was used to evaluate the hemodynamic profile of each participant.
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= SV * HR.
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Venous oxygen saturation is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. It reflects the amount of oxygen "left over" after the tissues consumption.
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
SVR was calculated using formula: ([mean systemic arterial pressure - mean right atrial pressure] divided by CO)*80, where CO= SV * HR.
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Measured: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements
Number of participants with unanticipated perioperative (occurring at or around the time of the surgery) and postoperative (period following the surgery) blood requirements were recorded on case report forms, summarized and reported in this outcome measure.
Measured: 0 to 24 hours post-separation from CPB
Duration of Assisted Ventilation
Assisted Ventilation time was the time (in hours) between intubation and extubation.
Measured: 0 hour up to 24 hours post-separation from CPB
Duration of Intensive Care Unit (ICU) Stay
Measured: 0 hour post-separation from CPB up to 44 days
Duration of Initial Postoperative Hospitalization
The duration of initial postoperative hospitalization had been reported.
Measured: 0 hour post-separation from CPB up to 44 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 200631 Mar 2008

First posted6 Feb 2009 (estimated)
Study start10 Aug 2006
Primary completion31 Mar 2008
Study completion31 Mar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac Surgery SubjectsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00838383
Sponsor's protocol ID: B1321004
Other IDs: B1321004, FCAD02-CARDIAC SURGERY
Acronym: FCAD02
Status last verified: Aug 2022
First submitted: 5 Feb 2009
Last updated: 8 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SELECTIVE ENDOTHELIN TYPE A RECEPTOR INHIBITION IN CARDIAC SURGERY SUBJECTS WITH PRE-EXISTING CARDIOVASCULAR RISK FACTORS: A DOSE CONFIRMATION STUDY
ClinicalTrials.gov ID: NCT00838383
Acronym / sponsor ID: FCAD02 / B1321004
Conditions: Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
Keywords: multi-center, placebo-controlled, randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 10 Aug 2006 (actual)
Primary completion: 31 Mar 2008 (actual)
Study completion: 31 Mar 2008 (actual)
First posted: 6 Feb 2009 (estimated)
Results: Posted 8 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
sitaxsentan (1.0 mg/kg)	Experimental	Drug: sitaxsentan (Thelin)
sitaxsentan (2.0 mg/kg)	Experimental	Drug: sitaxsentan (Thelin)
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 48 to 82 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Has been identified for coronary artery bypass grafting (CABG), aortic and/or mitral valve replacement, or combined CABG and cardiac valve replacement procedures that require cardiopulmonary bypass (CPB).

Key exclusion criteria (1 listed)

Requires an emergent or "emergency" CABG and/or cardiac valve replacement.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sitaxsentan (Thelin)Also: sitaxsentan, Thelinsitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.	Drug	sitaxsentan (1.0 mg/kg)
sitaxsentan (Thelin)Also: sitaxsentan, ThelinSitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.	Drug	sitaxsentan (2.0 mg/kg)
PlaceboPlacebo will begin immediately following cross-clamp release and 12 hours post-CPB.	Drug	Placebo

Primary outcome

Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0 hour, 0.5 hour post-separation from CPB
PVR in participants was derived from mean pulmonary artery pressure (PAP) (millimeter of mercury [mmHg]), pulmonary capillary wedge pressure (PCWP [mmHg]) and cardiac output (CO [litres per minute]). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= stroke volume (SV)*heart rate (HR). Post-separation from CPB was the time immediately following cross-clamp release in CPB. Percent change in PVR at 0.5 hour post-separation from CPB in participants were summarized and reported.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0 hour, 6 hour post-separation from CPB
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= SV * HR. Percent change in PVR at 6 hour in participants were summarized and reported.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0 hour, 12 hour post-separation from CPB
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= SV * HR. Percent change in PVR at 12 hour in participants were summarized and reported.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0 hour, 24 hour post-separation from CPB
PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: ([mean PAP-PCWP] divided by CO)*80, where CO= SV * HR. Percent change in PVR at 24 hour in participants were summarized and reported.
Mortality: Number of Participants Died During Surgery and Initial Hospitalization
Time frame: During surgery, initial hospitalization period (up to 29 days for 1 mg/kg group, up to 44 days for 2 mg/kg dose group, up to 19 days for placebo group)
Number of participants who died during surgery or during initial hospitalization are reported here.
Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation
Time frame: Initial hospitalization period (up to 44 days)
Number of participants with following incidents: myocardial infarction (Q and non-Q wave); stroke or cerebrovascular event (acute ischemia, hemorrhagic stroke or infarction, or a transient ischemia attack); hemodynamic collapse (requiring ventricular assistance devices) and re-operation (participants who returned to the operating room) during the initial hospitalization were reported.

16 secondary outcomes

Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period
Time frame: Immediately after cross-clamp removal up to 24 hours post-separation from CPB
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Time frame: 0, 0.5, 6, 12, 24 hours post-separation from CPB
Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements
Time frame: 0 to 24 hours post-separation from CPB
Duration of Assisted Ventilation
Time frame: 0 hour up to 24 hours post-separation from CPB
Duration of Intensive Care Unit (ICU) Stay
Time frame: 0 hour post-separation from CPB up to 44 days
Duration of Initial Postoperative Hospitalization
Time frame: 0 hour post-separation from CPB up to 44 days

Results and safety

Results posted to the registry on 8 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitaxsentan (1 mg/kg)	9	9
Sitaxsentan (2 mg/kg)	10	10
Placebo	10	10

Primary outcome: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)

Time frame: 0 hour, 0.5 hour post-separation from CPB. Mean (Standard Deviation). Unit: percent change

Measure	Sitaxsentan (1 mg/kg) n = 9	Sitaxsentan (2 mg/kg) n = 9	Placebo n = 10
Value	-7.75 (55.277)	-10.94 (37.967)	62.22 (260.172)

Sitaxsentan (1 mg/kg) vs Placebo: Mean Difference (Net): -70.0 (95% CI -291.3 to 151.4), p = 0.5307, ANCOVA
Sitaxsentan (2 mg/kg) vs Placebo: Mean Difference (Net): -73.2 (95% CI -294.5 to 148.2), p = 0.5121, ANCOVA

Population analysed: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Primary outcome: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB)

Time frame: 0 hour, 6 hour post-separation from CPB. Mean (Standard Deviation). Unit: percent change

Measure	Sitaxsentan (1 mg/kg) n = 9	Sitaxsentan (2 mg/kg) n = 9	Placebo n = 9
Value	39.36 (61.615)	-12.01 (39.561)	173.68 (511.269)

Sitaxsentan (1 mg/kg) vs Placebo: Mean Difference (Net): -123.1 (95% CI -345.5 to 99.3), p = 0.2735, ANCOVA
Sitaxsentan (2 mg/kg) vs Placebo: Mean Difference (Net): -174.5 (95% CI -396.8 to 47.9), p = 0.1223, ANCOVA

Primary outcome: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB)

Time frame: 0 hour, 12 hour post-separation from CPB. Mean (Standard Deviation). Unit: percent change

Measure	Sitaxsentan (1 mg/kg) n = 9	Sitaxsentan (2 mg/kg) n = 9	Placebo n = 10
Value	31.42 (67.887)	-12.32 (37.517)	98.03 (283.333)

Sitaxsentan (1 mg/kg) vs Placebo: Mean Difference (Net): -66.6 (95% CI -288.0 to 154.8), p = 0.5505, ANCOVA
Sitaxsentan (2 mg/kg) vs Placebo: Mean Difference (Net): -110.3 (95% CI -331.7 to 111.0), p = 0.3237, ANCOVA

Primary outcome: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB)

Time frame: 0 hour, 24 hour post-separation from CPB. Mean (Standard Deviation). Unit: percent change

Measure	Sitaxsentan (1 mg/kg) n = 9	Sitaxsentan (2 mg/kg) n = 8	Placebo n = 9
Value	18.06 (63.362)	-15.99 (41.604)	195.64 (522.379)

Sitaxsentan (1 mg/kg) vs Placebo: Mean Difference (Net): -166.5 (95% CI -389.6 to 56.6), p = 0.1412, ANCOVA
Sitaxsentan (2 mg/kg) vs Placebo: Mean Difference (Net): -199.8 (95% CI -425.0 to 25.5), p = 0.0813, ANCOVA

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitaxsentan (1 mg/kg)	2 of 9 (22.2%)	9 of 9 (100%)	Not reported
Sitaxsentan (2 mg/kg)	5 of 10 (50%)	9 of 10 (90%)	Not reported
Placebo	4 of 10 (40%)	9 of 10 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sitaxsentan (Thelin) in people with Cardiac Surgery Subjects and Subjects Undergoing CABG and/or Cardiac Valve Replacement, run by Pfizer at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) (time frame: 0 hour, 0.5 hour post-separation from CPB). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00838383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.