October 27, 2023
BRANTON, KS - The U.S. Food and Drug Administration (FDA) has approved an expanded indication for the hypertension medicine Brand X (fictusapril) to include treatment of high blood pressure in pediatric patients ages 6 to 17 years.
The new approval is based on a 16-week clinical trial demonstrating Brand X is safe and effective for lowering blood pressure in children and adolescents with hypertension.
A total of 267 pediatric patients aged 6 to 17 years with persistent high blood pressure were included in the double-blind, placebo-controlled trial.
Patients who received once-daily Brand X achieved significant reductions in both systolic and diastolic blood pressure from baseline at the end of the 16-week treatment period, compared to placebo.
The most common adverse reaction in pediatric patients was headaches. The safety profile was otherwise comparable to adult studies.
“This pediatric approval helps expand access to Brand X’s effective and well tolerated blood pressure lowering benefits to appropriate patients across ages,” said CEO of Pharma Co AG.
View the clinical study summary
To view the Brand X pediatric trial clinical study summary, click here.