18/10/2023
HYPERTrial demonstrates efficacy and safety of Brand X for treating hypertension
The highly anticipated results from the pivotal Phase 3 HYPERTrial (NCT04695659) were published today in The Journal of Clinical Hypertension, providing compelling evidence supporting the use of Brand X for treating stage 1 and 2 hypertension.
Trial Design
This randomized, double-blind, placebo-controlled trial enrolled 1,512 men and women aged 18-75 years across 187 clinical sites in the United States and Canada.
Eligible participants had a baseline systolic blood pressure between 140-180 mmHg and diastolic blood pressure under 110 mmHg. 45% had stage 1 hypertension and 55% had stage 2. 19% of participants had diabetes.
Participants were randomized 1:1 to receive a once daily oral dose of either Brand X 20mg or visually identical placebo for 12 weeks. The dose was uptitrated to 40mg and then 80mg at 4 week intervals if blood pressure exceeded 120/80 mmHg.
Efficacy Results
After 12 weeks, patients receiving Brand X achieved statistically significant reductions in both systolic and diastolic BP from baseline compared to the placebo group:
- Mean change in systolic BP was -12.2 mmHg for Brand X vs -0.3 mmHg for placebo
- Mean diastolic BP change was -8.4 mmHg for Brand X vs -0.5 mmHg for placebo
The treatment difference between Brand X and placebo of -11.9 mmHg systolic and -7.9 mmHg diastolic was highly statistically significant (p<0.0001).
Around 60% of Brand X patients reached target BP control of under 120/80 mmHg on the maximum 80mg daily dose. Blood pressure lowering was consistent across gender, age, race, and comorbidity subgroups.
Safety Outcomes
Brand X was generally well-tolerated over the 12 week treatment period. The overall incidence of adverse events was comparable between the Brand X group (58%) and placebo group (56%).
Discontinuation rates due to side effects were 5.2% for Brand X versus 3.8% for placebo. The most common adverse events reported were dizziness (12.3% vs 2.1% for placebo), headache (5.4% vs 4.0% placebo), and fatigue (4.2% vs 2.3% placebo).
There were no notable changes in laboratory measures, vital signs, or ECG parameters compared to placebo.
Conclusions
“The robust efficacy and favorable safety demonstrated in this rigorously conducted trial provides compelling evidence supporting the use of Brand X as an effective treatment option for hypertension,” concluded lead author Dr. Linda Park.