A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00159874
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
• Scientific title: A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131
• Date of first enrolment: January 2004
• Target sample size: 234
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00159874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Brazil, Canada, Chile, Colombia, Costa Rica, Guatemala, Hungary, India, Italy, Japan, Malaysia, Mexico, Panama, Poland, Russian Federation, Singapore, Sweden, Taiwan, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must complete the 16 Week double-blind efficacy study A1481131.

Exclusion Criteria:

- Any patient who did not complete Study A1481131.



Age minimum: 1 Year
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Sildenafil citrate

Primary Outcome(s)

Discontinuation Due to Intolerability [Time Frame: Throughout the treatment duration (median treatment duration 1689 to 1744 days)]

Number of Participants Reporting Treatment-related Serious Adverse Events [Time Frame: Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)]

Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration [Time Frame: Pre-DMC Recommendation dose down titration (04 August 2011)]

Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests [Time Frame: Week 36]

Pediatric Motor Development Status at Week 16. [Time Frame: Week 16]

Downtitration in Dose Due to Intolerability. [Time Frame: Pre-DMC recomendation (04 August 2011)]

Number of Participants Reporting at Least One Serious Adverse Event [Time Frame: Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)]

Pediatric Motor Development Status at Week 52 [Time Frame: Week 52]

Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests. [Time Frame: Week 36]

Number of Deaths Reported During This Study [Time Frame: Last follow-up visit or 30 days after the last administration of study drug]

Pediatric Cognitive Development Status at Week 52. [Time Frame: Week 52]

Pediatric Cognitive Development Status at Week 16. [Time Frame: Week 16]

Number of Participants Reporting at Least One Adverse Event [Time Frame: Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)]

Number of Participants Reporting Treatment-related Adverse Events [Time Frame: Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)]

Secondary Outcome(s)

Physician Global Assessment at Year 1 [Time Frame: Year 1]

Percent Change From Baseline in Time to Maximum VO2 at Year 1 [Time Frame: Baseline, Year 1]

Percentage Change From Baseline in Percent Predicted Peak VO2 at Year 1. [Time Frame: Baseline, Year 1]

Summary of Shift in Changes From Start of Sildenafil in World Health Organization Pulmonary Hypertension (WHO PH) Functional Class by A1481156 Treatment Group at Year 1. [Time Frame: Baseline, Year 1]

Peak Volume of Oxygen (VO2) Consumed at Year 1 Using a Bicycle Ergometry Cardiopulmonary Exercise Test (CPX) [Time Frame: 1 year]

Percentage Change From Baseline in Anaerobic Threshold at Year 1. [Time Frame: Baseline, Year 1]

Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 3. [Time Frame: Baseline, Year 3]

Percent Change From Start of Sildenafil in Total Ventilation (VE) to Year 1 [Time Frame: Year 1]

Percentage Change From Baseline in End Tidal Oxygen (O2) at Year 1. [Time Frame: Baseline, Year 1]

Participant (Parent) Global Assessment at Year 1 [Time Frame: Year 1]

Percent Change From Baseline in Respiratory Exchange Ratio at Year 1 [Time Frame: Baseline, Year 1]

Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 2. [Time Frame: Baseline, Year 2]

Additions From Baseline in Background Therapy up to the End of Study [Time Frame: Up to the end of study]

Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Psychosocial Scale at Year 1. [Time Frame: Baseline, Year 1]

Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at Year 1. [Time Frame: Baseline, Year 1]

Percentage Change From Baseline in End Tidal Carbon Dioxide (CO2) at Year 1. [Time Frame: Baseline, Year 1]

Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 4. [Time Frame: Baseline, Year 4]

Secondary ID(s)

A1481156

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/08/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00159874