27/10/2023
A 16-week, randomized, double-blind, placebo-controlled Phase 3 trial published in Pediatrics demonstrated Brand X safely and effectively reduces elevated blood pressure in hypertensive children aged 6-17 years.
Trial Design
This multinational trial enrolled 267 children aged 6-17 with primary hypertension across 76 sites in North America and Europe.
Participants had baseline systolic blood pressure at or above the 95th percentile. 54% were male, mean age was 12 years.
Participants were randomized 1:1 to receive once daily Brand X or placebo for 16 weeks. Brand X was weight-based dosed starting at 5mg for under 50kg or 10mg for over 50kg.
Efficacy Results
After 16 weeks, patients receiving Brand X experienced significant mean reductions from baseline in systolic and diastolic BP of 10.2/6.1 mmHg, compared to 4.1/1.9 mmHg with placebo.
The treatment difference between Brand X and placebo of 6.1 mmHg systolic and 4.2 mmHg diastolic BP reduction was highly statistically significant (p<0.0001).
Over 60% of patients achieved adequate systolic BP control to under the 95th percentile with Brand X versus 37% for placebo. Efficacy was similar across demographic subpopulations.
Safety Outcomes
Brand X was generally well tolerated. The incidence of overall adverse events was similar between groups at 62% for Brand X and 59% for placebo.
Headache was the most common side effect, occurring in 12% of Brand X patients versus 10% for placebo. Discontinuation due to adverse events was low at 5% for Brand X versus 3% for placebo.
There were no significant changes in lab measures, vital signs, or ECG parameters. The safety profile was comparable to studies in adults.
Conclusions
“This data provides evidence that Brand X is an effective and well tolerated treatment that should be considered for children with primary hypertension,” concluded lead investigator Dr. Ann Bauer.