06/10/2023
Results from the Phase 3 HYPER-1 trial were published today in The New England Journal of Medicine, providing compelling evidence supporting the use of Brand X for treating stage 1 and 2 hypertension.
Trial Design
The HYPER-1 trial was a 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study evaluating the antihypertensive efficacy and safety of Brand X in 1,512 patients aged 18-75 years with stage 1 or 2 primary hypertension (ClinicalTrials.gov Identifier: NCT04695659).
Participants were randomized 1:1 to receive either Brand X 20mg or placebo once daily for 12 weeks. Study drug could be uptitrated to 40mg and 80mg at 4 and 8 weeks if trough cuff blood pressure exceeded 120/80 mmHg.
The primary endpoint was change from baseline in trough cuff systolic blood pressure (SBP) at week 12. Secondary endpoints included change in diastolic BP, achievement of BP control, and ambulatory BP monitoring.
Efficacy Results
Treatment with Brand X resulted in statistically significant reductions in SBP and DBP from baseline versus placebo:
- Mean change SBP: -12.2 mmHg Brand X vs -0.3 mmHg placebo
- Mean change DBP: -8.4 mmHg Brand X vs -0.5 mmHg placebo
60% of Brand X patients achieved BP control <120/80 mmHg on the maximum daily dose of 80mg.
BP lowering was consistent irrespective of baseline disease severity or demographic factors.
Safety Outcomes
The overall incidence of adverse events was comparable between the Brand X (58%) and placebo groups (56%).
The most common side effects were mild dizziness (12.3% vs 2.1% for placebo), headache (5.4% vs 4.0%), and fatigue (4.2% vs 2.3%).
Discontinuations due to adverse events were 5.2% for Brand X versus 3.8% with placebo. There were no unexpected safety findings.
Conclusions
The HYPER-1 trial provides robust evidence that Brand X is an effective and well tolerated treatment option for patients with stage 1 or 2 hypertension.