At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
Tadalafil- Tablet or Oral suspensiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension
In Brief
A Phase 2 clinical trial evaluating Tadalafil- Tablet or Oral suspension for Pulmonary Arterial Hypertension. Completed, enrolled 20 participants across 16 sites in 6 countries.
Detailed Summary
The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesCanada, France, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartJul 2012
Primary CompletionApr 2017
Study CompletionApr 2019
TodayJul 2026
First PostedDec 2, 2011
Enrollment StartJul 17, 2012
Primary CompletionApr 21, 2017
Study CompletionApr 3, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.6 years ago
Interventions
Tadalafil- Tablet or Oral suspensiondrug
Tadalafil Tablets administered orally. Tadalafil Oral suspension: An aqueous, ready-to-use suspension for oral administration.