Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sildenafil (as citrate)
CAS Number: N/A
Other descriptive name: UK-92,480
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Pediatric subjects, who enrolled in and completed Study A1481131; · Females of childbearing potential who are sexually active must be practicing a suitable method of birth control so that in the opinion of the investigator, they will not become pregnant during the study; and · The investigator must obtain written informed consent and assent where applicable before the subject is considered for enrollment in Study A1481156. The inclusion of a subject more than once in the same clinical trial is not permissible. All inclusion criteria must be adhered to. Are the trial subjects under 18? yes Number of subjects for this age range: 217 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pediatric subjects, who did not complete Study A1481131. • Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic anterior ischemic optic neuropathy (NAION). The exclusion criteria must be adhered to.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and tolerability of oral sildenafil in the chronic treatment of pediatric subjects with PAH. ;Secondary Objective: The secondary objectives are; - To describe long-term (=1 year) efficacy of oral sildenafil in these subjects - To assess survival status of subjects who have discontinued study drug;Primary end point(s): Safety Parameters: · Standard safety data; · Ocular safety measures: Change from A1481156 baseline in ocular safety tests; · Need for downtitration in dose due to intolerability; · Need for discontinuation due to intolerability; and · Growth and development. Other Outcome Parameters: To assess 1-year efficacy data, the following endpoints will be described; Percent change from A1481131 baseline to Week 36 of the extension Study A1481156 in the following exercise endpoints in subjects who are developmentally able to perform the CPX test: · Peak VO2 normalized to body weight using an exercise tolerance test (bicycle ergometry); · Respiratory Exchange Ratio (RER); · Time to maximum VO2; · Total ventilation (VE); Change from A1481131 baseline to Week 36 of the extension Study A1481156 in: · CHQ-PF28 as assessed by the physical and psychosocial scales; · WHO PH functional class; · End tidal O2 and CO2; · Anaerobic threshold (AT); · Percent predicted peak VO2 in subjects who are developmentally able to perform the CPX test; · Subject (Parent)/Physician global assessment; · Background therapy. To assess sustainability of effect after A1481131, the following endpoints will be described; From A1481156 baseline to assessment times specified in study schedule: · Percent change in peak VO2 normalized to body weight using an exercise tolerance test (bicycle ergometry) in subjects developmentally able to perform the exercise; · Change in CHQ PF28 scales; · Change in WHO PH functional class. ;Timepoint(s) of evaluation of this end point: Weeks 12,24,36, 48 every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Long-term Efficacy:'Other Outcome Parameters: To assess 1-year efficacy data, the following endpoints will be described; Percent change from A1481131 baseline to Week 36 of the extension Study A1481156 in the following exercise endpoints in subjects who are developmentally able to perform the CPX test: •Peak VO2 normalized to body weight using an exercise tolerance test (bicycle ergometry); •Respiratory Exchange Ratio (RER); •Time to maximum VO2; •Total ventilation (VE); Change from A1481131 baseline to Week 36 of the extension Study A1481156 in: •CHQ-PF28 as assessed by the physical and psychosocial scales; •WHO PH functional class; •End tidal O2 and CO2; •Anaerobic threshold (AT); •Percent predicted peak VO2 in subjects who are developmentally able to perform the CPX test; •Subject (Parent)/Physician global assessment; •Background therapy. To assess sustainability of effect after A1481131, the following endpoints will be described; From A1481156 baseline to assessment times specified in study schedule: •Percent change in peak VO2 normalized to body weight using an exercise tolerance test (bicycle ergometry) in subjects developmentally able to perform the exercise;Timepoint(s) of evaluation of this end point: Weeks 12,24,36, 48 every 12 weeks | — |
Countries
Brazil, Chile, Colombia, Costa Rica, Finland, Guatemala, Hungary, India, Italy, Malaysia, Mexico, Poland, Russian Federation, Sweden, Taiwan, Thailand, United Kingdom
Contacts
Public ContactClinical Trials gov Call cneter
Pfizer Inc
Outcome results
None listed