Study: NCT00568178

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Losartan Potassium
Description: Losartan Use During the Double-Blind Treatment Phase:~Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed \<50 kg)~or 100 mg/day (if the patient weighed ≥50 kg).~Losartan Use During the Treatment Extension Phase:~Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Losartan Potassium
Description: Losartan Use During the Double-Blind Treatment Phase:~Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed \<50 kg)~or 100 mg/day (if the patient weighed ≥50 kg).~Losartan Use During the Treatment Extension Phase:~Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Comparator: Placebo (Losartan)
Description: Placebo (losartan suspension), administered orally, once daily for 12 weeks

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Comparator: Placebo (Losartan)
Description: Placebo (losartan suspension), administered orally, once daily for 12 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Comparator: amlodipine besylate
Description: Amlodipine besylate (1 mg/mL) liquid suspension, oral administration, titrated to 0.2 mg/kg/day (5 mg maximum dose) per day for 12 Weeks

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Comparator: Placebo (amlodipine besylate)
Description: Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Placebo (Losartan)
Description: Normotensive patients randomized to losartan placebo for 12 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Enalapril Maleate
Description: Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.