A Phase 3 interventional study of Sitaxentan in Hypertension, Pulmonary, sponsored by Pfizer. Terminated at 2 sites in Japan. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-12-14.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the long-term safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 2 is below the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sitaxentan
sitaxentan sodium 100 mg
Number of Participants With Adverse Events
Number of participants with any adverse events, severe adverse events, serious adverse events
Time frame: Up to 22 days (last participant discontinuation)
Percentage of Participants With Clinical Worsening
Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.
Time frame: Up to 22 days (last participant discontinuation)
Change From Baseline in 6-Minute Walk Distance
Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.
Time frame: Up to 22 days (last participant discontinuation)
Percentage of Participants With Change From Baseline in WHO Functional Class
The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48).
Time frame: Up to 22 days (last participant discontinuation)
Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)
Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.
Time frame: Up to 22 days (last participant discontinuation)
| Milestone | Sitaxentan Treatment |
|---|---|
| Started | 2 |
| Completed | 0 |
| Not completed | 2 |
| Withdrew: Study terminated by sponsor | 2 |
Number of participants with any adverse events, severe adverse events, serious adverse events
| Participants | Sitaxentan Treatment |
|---|---|
| Treatment emergent all-causality adverse events | 1 |
| Treatment emergen-causality serious adverse events | 0 |
| Treatment emergent all-causality severe adverse ev | 0 |
Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.
No measurements were reported for this outcome.
Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.
No measurements were reported for this outcome.
The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48).
No measurements were reported for this outcome.
Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitaxentan Treatment | — | 0/2 (0%) | 1/2 (50%) |
| Event | Sitaxentan Treatment |
|---|---|
| DiarrhoeaGastrointestinal disorders | 1/2 |
| HeadacheNervous system disorders | 1/2 |
| Age, Customized(Participants) | Sitaxentan Treatment |
|---|---|
| <=18 years | 0 |
| 19-64 years | 1 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Sitaxentan Treatment |
|---|---|
| Female | 2 |
| Male | 0 |
This study is terminated, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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