MK-0954/Losartan Potassium in Paediatric Patients With Hypertension

• Research type

  Research Study

• Full title

  A Phase III, Randomised, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK-0954/Losartan Potassium in Paediatric Patients With Hypertension

• IRAS ID

  12402

• Contact name

  Nicholas Webb

• Sponsor organisation

  Merck & Co.,Inc.

• Eudract number

  2008-004732-20

• ISRCTN Number

  N/A

• Research summary

  Losartan is a licensed drug used for hypertension and has been shown to be effective in adults and has shown promising results in two previous studies in older children. This study, sponsored by Merck & Co. Inc, aims to explore the dose response relationship of losartan and its safety and tolerability in hypertensive children aged 6 months to 6 years. This is a 12-week, open-label study, approximately 100 patients to be recruited worldwide, 6 patients anticipated from the UK, will be randomly assigned to the following treatment groups: 0.1/0.3/0.7 mg/kg/day of Losartan. These doses will be increased sequentially to the next higher dose at each of the dose titration visits at weeks 3, 6 and 9 if the patient has not reached their blood pressure (BP) goal. The maximum dose will be 1.4 mg/kg/day if not at BP goal (patients randomized to third group will only have one dose titration to 1.4 mg/kg/day). If a patient has still not reached their BP goal on the maximum dose of losartan, the Investigator may prescribe additional medication. Depending when they entered the 12-week base study, patients who complete the base study may be invited to continue in the open-label losartan extension with follow-up visits every 3 months. The duration of follow-up will be variable for each patient, and at the longest, will last until either that patient has reached the month 24 visit of the extension or until the final patient enrolled (100th) completes the 12-week base, whichever comes first. Study visits will check for safety (blood testing, vital signs, adverse events), an ECG (electrocardiogram to measure the heart??s electrical activity) will be performed at the first visit and child??s growth and maturation will be measured. Approximately 50 children will be asked to have an Echocardiogram (an ultrasound examination of the heart)

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  08/H1008/215

• Date of REC Opinion

  24 Mar 2009

• REC opinion

  Further Information Favourable Opinion