Pulmonary Arterial HypertensionPhase 3NCT00796510
Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
A Phase 3 study testing Sitaxsentan and Sitaxsentan and Sildenafil in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by Pfizer at 3 sites in 3 countries.
Trial summary
As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination. 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 and Sitaxsentan and Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2010to Jan 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
- Previously enrolled in B1321001 for at least 4 weeks.
- Previously enrolled in B1321003, discontinued from the study.
- Completed the B1321003 study as planned.
Who cannot join
- Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Pfizer Investigational Site
Fountain Valley, California, 92708
About this study
Official title: A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension
As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.
- Being tested
- Sitaxsentan, Sitaxsentan and Sildenafil
- Keywords
- endothelin receptor antagonist (ETRA), sitaxsentan
- 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
Sitaxsentan and SildenafilDrug
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
| Study group | Role | What they receive |
|---|---|---|
| Sitaxsentan | Experimental | Monotherapy arm Receives: Drug: Sitaxsentan |
| Sitaxsentan and Sildenafil | Experimental | Combination treatment Receives: Drug: Sitaxsentan and Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
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.
Measured: Baseline and every 12 weeks up to Week 18
Secondary outcomes (2)
Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24
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.
Measured: Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)
Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)
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).
Measured: Baseline, Week 12 and ET (up to Week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJan 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT00796510
- Sponsor's protocol ID
- B1321002
- Status last verified
- Sep 2018
- First submitted
- 20 Nov 2008
- Last updated
- 25 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00796510
- Acronym / sponsor ID
- B1321002
- Keywords
- endothelin receptor antagonist (ETRA), sitaxsentan
- 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
- 3 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 20 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitaxsentan | Experimental | Drug: SitaxsentanMonotherapy arm |
| Sitaxsentan and Sildenafil | Experimental | Drug: Sitaxsentan and SildenafilCombination treatment |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Previously enrolled in B1321001 for at least 4 weeks.
- Previously enrolled in B1321003, discontinued from the study.
- Completed the B1321003 study as planned.
Key exclusion criteria (1 listed)
- Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.
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 |
| Sitaxsentan and SildenafilSitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day | Drug | Sitaxsentan and Sildenafil |
Primary outcome
Overall Survival
Time frame: 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.
2 secondary outcomes
Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24
Time frame: Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)
Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)
Time frame: Baseline, Week 12 and ET (up to Week 18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- 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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitaxsentan and Sitaxsentan and Sildenafil in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by Pfizer at 3 sites in 3 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 3 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 25 Oct 2018. 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, Romania, Ukraine. 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. 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 20 Feb 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?
Overall Survival (time frame: Baseline and every 12 weeks up to Week 18). 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 25 Oct 2018.