Hypertension, Pulmonary
Conditions
Keywords
sitaxentan sodium pulmonary hypertension
Brief summary
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.
Interventions
DRUGSitaxentan
sitaxentan sodium 100 mg
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject who completed the B1321052 study as planned.
Exclusion criteria
* Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \>160 mm Hg or sitting diastolic blood pressure \>100 mm Hg at Screening. * Has hypotension defined as systolic arterial pressure \<90 mm Hg after sitting for 5 minutes at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to 22 days (last participant discontinuation) | Number of participants with any adverse events, severe adverse events, serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Worsening | Up to 22 days (last participant discontinuation) | 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. |
| Change From Baseline in 6-Minute Walk Distance | Up to 22 days (last participant discontinuation) | 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. |
| Percentage of Participants With Change From Baseline in WHO Functional Class | Up to 22 days (last participant discontinuation) | 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). |
| Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | Up to 22 days (last participant discontinuation) | 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. |
Countries
Japan
Participant flow
Pre-assignment details
Participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks in preceding B1321052 study.
Participants by arm
| Arm | Count |
|---|---|
| Sitaxentan Treatment All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study terminated by sponsor | 2 |
Baseline characteristics
| Characteristic | Sitaxentan Treatment |
|---|---|
| Age, Customized <=18 years | 0 Participants |
| Age, Customized 19-64 years | 1 Participants |
| Age, Customized >=65 years | 1 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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)
Population: The safety analysis set is defined as all subjects who receive at least one dose of study drug during this extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxentan Treatment | Number of Participants With Adverse Events | Treatment emergent all-causality adverse events | 1 Participants |
| Sitaxentan Treatment | Number of Participants With Adverse Events | Treatment emergen-causality serious adverse events | 0 Participants |
| Sitaxentan Treatment | Number of Participants With Adverse Events | Treatment emergent all-causality severe adverse ev | 0 Participants |
Secondary
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)
Population: The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants.
Secondary
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)
Population: The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants.
Secondary
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)
Population: The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants.
Secondary
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)
Population: The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants.