TAK 491 study in hypertensive children

• Research type

  Research Study

• Full title

  A Comparative Single-Dose Pharmacokinetic and Safety Study of TAK-491 Between Infants, Children, and Adolescents With Hypertension and Healthy Adults

• IRAS ID

  35450

• Contact name

  Nick Webb

• Sponsor organisation

  Takeda Development Centre Europe Ltd

• Eudract number

  2009-013165-25

• Research summary

  Within the past 10 years, the incidence of high blood pressure (hypertension) in children and adolescents has increased all over the world. This increase is connected in part to a growing number of people who are overweight and do not eat right or exercise enough. This study will look at a new and untested blood pressure medicine called TAK-491 to see how it works in children who have hypertension. Adults who do not have hypertension will also take part in this study to provide a comparison. To be eligible to take part in this study, children must be between the ages of 6 months and 16 years old, and will have to stop taking their current antihypertensive medication for one day prior to the start of this study. Each child will be given one dose of TAK-491, followed by a number of blood tests and assessments within 24 hours after taking TAK-491 to see how the medication is working. This study will take place in 8 sites in the UK and USA. A total of 24 children with hypertension and 8 adults without hypertension will take part in this study. Each person taking part in this study will be required to attend 2 to 3 study related hospital visits. This study will last about 43 days. This includes a 28 day screening period, a 2 day treatment phase and a follow up period. Each person taking part in this study may be requested to remain in a hospital for one overnight stay during the course of the study. Each participant will also be contacted by telephone 6 days and 15 days after taking TAK-491.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1002/1

• Date of REC Opinion

  26 Feb 2010

• REC opinion

  Further Information Favourable Opinion