Pulmonary Arterial Hypertension, Pulmonary Hypertension
Conditions
Keywords
endothelin receptor antagonist (ETRA), sitaxsentan
Brief 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.
Interventions
DRUGSitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Previously enrolled in B1321001 for at least 4 weeks. * Previously enrolled in B1321003, discontinued from the study. * Completed the B1321003 study as planned.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24 | Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18) | 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. |
| Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH) | Baseline, Week 12 and ET (up to Week 18) | 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). |
Countries
Romania, Ukraine, United States
Participant flow
Recruitment details
Participants were previously enrolled in B1321001 (NCT00795639) or B1321003 (NCT00796666) only where pre-specified entry criteria were met.
Participants by arm
| Arm | Count |
|---|---|
| Sitaxsentan Sitaxsentan 100 milligrams (mg) orally once a day | 3 |
| Sitaxsentan and Sildenafil Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day | 0 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Study Terminated | 2 | 0 |
Baseline characteristics
| Characteristic | Sitaxsentan | Total |
|---|---|---|
| Age, Continuous | 42.3 years | 42.3 years |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 3 | 0 / 0 |
| serious Total, serious adverse events | 1 / 3 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Baseline and every 12 weeks up to Week 18
Population: Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.
Secondary
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.
Time frame: Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)
Population: Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.
Secondary
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).
Time frame: Baseline, Week 12 and ET (up to Week 18)
Population: Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.