Study of Tadalafil in Children with Pulmonary Arterial Hypertension(a)

• Research type

  Research Study

• Full title

  A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a paediatric population with Pulmonary Arterial Hypertension

• IRAS ID

  92005

• Contact name

  Ingram Schulze-Nieck

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2011-001873-24

• ISRCTN Number

  ISRCTN

• Research summary

  H6D-MC-LVIG(a) is a small-scale ascending-dose multicentre study in children aged 6 months to 17 years with pulmonary arterial hypertension. The aim of the study is to determine the oral doses of tadalafil to use in future research in children. Patients will not be able to participate if they have left-sided heart disease or other significant medical problems. 24 children will take part in the study, which will last for about 6 years. This study is divided into 2 treatment phases: - Period 1; a 10 week dose-ascending phase #- Period 2; a long-term treatment phase lasting up to 2 years Study assessments will be done at the start of study treatment; 1, 2, 4, 5, 6, 7 and 10 weeks after starting study treatment; and then at 3 monthly intervals for up to 2 years. The study procedures will include: - reviews of medical history and medication use - a pulmonary function test in patients aged 6 years or more - physical examinations - eye examinations - heart rate, blood pressure, height and weight measurements - electrocardiograms (heart traces) - World Health Organisation functional class assessment - blood collection for safety tests, genetic analysis, and measurement of blood tadalafil and n-terminal prohormone-brain natriuretic peptide. Inhibin B will also be measured in male patients. - urine collection for safety tests, drug screening, and, in females of childbearing potential, pregnancy tests - a chest X-ray if one has not been done within the previous 6 months - 6-minute walking tests in patients aged 7 or more - IQ testing - oral suspension palatability questionnaire completion, where applicable When the patient stops taking part in the study, study medication will not be available. The study doctor will discuss treatment options with the patient and their parent/guardian.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/0050

• Date of REC Opinion

  29 Mar 2012

• REC opinion

  Further Information Favourable Opinion