Pulmonary Hypertension
Conditions
Brief summary
The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment of PAH in Poland. Only safety and tolerability data will be collected in these patients.
Interventions
DRUGsildenafil
tablets, 20mg, TID, 112 weeks at the maximum
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 18 and over who have any of the following conditions: * Idiopathic pulmonary arterial hypertension. * PAH associated with connective tissue disease (CTD). * PAH with surgical repair, at least 5yrs previously, of atrial septal defect (ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or aorta-pulmonary window. 2. Subjects with a mean pulmonary artery pressure (mPAP) \> 25mmHg and a pulmonary artery wedge pressure (PAWP) \< 15mmHg at rest, assessed via right heart catheterization. 3. Subjects whose baseline 6-min walk test distance was \> 100m and \< 450m.
Exclusion criteria
1. PAH secondary to any etiology other than those specified in the inclusion criteria. 2. Subjects with congenital heart disease (other than those specified in the inclusion criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease, congestive heart failure. 3. Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 116 Weeks | Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sildenafil 60 mg Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension) | 20 |
| Sildenafil 240 mg Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142 | 12 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 2 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Sildenafil 60 mg | Sildenafil 240 mg | Total |
|---|---|---|---|
| Age, Customized 18 - 44 years | 10 participants | 6 participants | 16 participants |
| Age, Customized 45 - 64 years | 8 participants | 6 participants | 14 participants |
| Age, Customized >= 65 years | 2 participants | 0 participants | 2 participants |
| Sex: Female, Male Female | 17 Participants | 9 Participants | 26 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 20 | 8 / 12 |
| serious Total, serious adverse events | 8 / 20 | 2 / 12 |
Outcome results
Primary
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect.
Time frame: Baseline up to 116 Weeks
Population: Safety population: all subjects assumed to have taken at least one dose of study medication. Non-serious adverse events were reported up to 7 days after the last dose of study medication. Serious adverse events were reported up to 28 days after the last dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sildenafil 60 mg | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 11 participants |
| Sildenafil 60 mg | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 8 participants |
| Sildenafil 240 mg | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 8 participants |
| Sildenafil 240 mg | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |