Pulmonary Arterial HypertensionPhase 3NCT00795639
Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
A Phase 3 study testing Sitaxsentan in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by Pfizer at 85 sites in 24 countries.
Trial summary
This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Pulmonary Hypertension
- What is being tested?
- Sitaxsentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 85 sitesin 24 countries
- Study dates
- Dec 2008to Mar 2011
- Phase
- Phase 3
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.
Who cannot join
- Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.
Trial locations and contacts
85 sites in 24 countries.
85 sites in 24 countries
United States32 sites
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Dallas, Texas, 75390
Pfizer Investigational Site
Englewood, Colorado, 80113
Pfizer Investigational Site
Fountain Valley, California, 92708
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Islandia, New York, 11749
Pfizer Investigational Site
Lancaster, Pennsylvania, 17602
Pfizer Investigational Site
Lancaster, Pennsylvania, 17603
Pfizer Investigational Site
Littleton, Colorado, 80120
Pfizer Investigational Site
Lynchburg, Virginia, 24501
Pfizer Investigational Site
Mather, California, 95655
Pfizer Investigational Site
Milwaukee, Wisconsin, 53215
Pfizer Investigational Site
New Brunswick, New Jersey, 08903
Pfizer Investigational Site
Olathe, Kansas, 66061
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19140
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15212
Pfizer Investigational Site
Providence, Rhode Island, 02903
Pfizer Investigational Site
Richmond, Virginia, 23225
Pfizer Investigational Site
Sacramento, California, 95817
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Sarasota, Florida, 34233
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
Temple, Texas, 76508
Pfizer Investigational Site
Towson, Maryland, 21204
Pfizer Investigational Site
Weston, Florida, 33331
India8 sites
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 060
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641 014
Pfizer Investigational Site
Hyderabad, Andhera Pradesh, 500 063
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 001
Pfizer Investigational Site
Madurai, Tamil Nadu, 625 107
Pfizer Investigational Site
Pune, Maharashtra, 411 030
Pfizer Investigational Site
Surat, Gujarat, 395 007
Pfizer Investigational Site
Vadodara, Gujarat, 390 015
China5 sites
Pfizer Investigational Site
Beijing, 100032
Pfizer Investigational Site
Changsha, Hunan, 410008
Pfizer Investigational Site
Shanghai, 200001
Pfizer Investigational Site
Shanghai, 200433
Pfizer Investigational Site
Xi’an, Shanxi, 710032
Russia5 sites
Pfizer Investigational Site
Moscow, 105077
Pfizer Investigational Site
Moscow, 121552
Pfizer Investigational Site
Saint Petersburg, 194156
Pfizer Investigational Site
Saint Petersburg, 197022
Pfizer Investigational Site
Saint Petersburg, 197341
Argentina4 sites
Pfizer Investigational Site
Buenos Aires, C1039AAO
Pfizer Investigational Site
Buenos Aires, C1428DCO
Pfizer Investigational Site
Buenos Aires, C1428DUS
Pfizer Investigational Site
Buenos Aires, C1431FWO
South Africa4 sites
Pfizer Investigational Site
Cape Town, Western Cape, 7531
Pfizer Investigational Site
Cape Town, 7500
Pfizer Investigational Site
Johannesburg, 2193
Pfizer Investigational Site
Stellenbosch, 7600
Bulgaria3 sites
Pfizer Investigational Site
Sofia, 1202
Pfizer Investigational Site
Sofia, 1233
Pfizer Investigational Site
Veliko Tarnovo, 5000
Mexico3 sites
Pfizer Investigational Site
Mexico City, Mexico City, 14000
Pfizer Investigational Site
Mexico City, Mexico City, 14080
Pfizer Investigational Site
Monterrey, Nuevo León, 64718
Dominican Republic2 sites
Pfizer Investigational Site
Santo Domingo, República Dominicana, 00000
Pfizer Investigational Site
Santo Domingo, Santo Domingo Province, 4966
Peru2 sites
Pfizer Investigational Site
Lima, 13
Pfizer Investigational Site
Lima, 32
Romania2 sites
Pfizer Investigational Site
Cluj-Napoca, Romania, 400 001
Pfizer Investigational Site
Iași, 700 503
Thailand2 sites
Pfizer Investigational Site
Bangkok, 10330
Pfizer Investigational Site
Bangkoknoi, Bangkok, 10700
Ukraine2 sites
Pfizer Investigational Site
Kyiv, 03680
Pfizer Investigational Site
Kyiv
Costa Rica1 site
Pfizer Investigational Site
Escazú, Provincia de San José, 00000
Guatemala1 site
Pfizer Investigational Site
Guatemala City, Departamento de Guatemala
Turkey (Türkiye)1 site
Pfizer Investigational Site
Istanbul, Fatih, 34080
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension
This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.
- Being tested
- Sitaxsentan, Placebo
- Keywords
- Sitaxsentan, endothelin receptor antagonist
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitaxsentanDrug
Sitaxsentan = 100 mg tablet administered orally, once daily
PlaceboDrug
Also called Sitaxsentan Placebo
Sitaxsentan Placebo = 1 tablet administered orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| Sitaxsentan | Experimental | Monotherapy Receives: Drug: Sitaxsentan |
| Sitaxsentan Placebo | Placebo comparator | Monotherapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at 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.
Measured: Baseline/Day 1 and Week 12
Secondary outcomes (2)
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12
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.
Measured: Baseline, Weeks 4, 8 and 12 or Early Termination (ET)
Time to Clinical Worsening (TTCW)
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.
Measured: Baseline, Weeks 4, 8 and 12 or ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.
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 Pulmonary Arterial HypertensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795639
- Sponsor's protocol ID
- B1321001
- Status last verified
- Mar 2015
- First submitted
- 20 Nov 2008
- Last updated
- 24 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00795639
- Acronym / sponsor ID
- B1321001
- Keywords
- Sitaxsentan, endothelin receptor antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.
- Enrolment
- 183 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Posted 1 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitaxsentan | Experimental | Drug: SitaxsentanMonotherapy |
| Sitaxsentan Placebo | Placebo comparator | Drug: PlaceboMonotherapy |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.
Key exclusion criteria (1 listed)
- Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.
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 |
|---|---|---|
| SitaxsentanSitaxsentan = 100 mg tablet administered orally, once daily | Drug | Sitaxsentan |
| PlaceboAlso: Sitaxsentan PlaceboSitaxsentan Placebo = 1 tablet administered orally, once daily | Drug | Sitaxsentan Placebo |
Primary outcome
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12
Time frame: 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.
2 secondary outcomes
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12
Time frame: Baseline, Weeks 4, 8 and 12 or Early Termination (ET)
Time to Clinical Worsening (TTCW)
Time frame: Baseline, Weeks 4, 8 and 12 or ET
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- 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.
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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
85 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitaxsentan in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by Pfizer at 85 sites in 24 countries.
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: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, India, China, Russia, Argentina and 19 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 1 Mar 2012). 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?
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12 (time frame: Baseline/Day 1 and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2015.