A Multicentre, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1893 Tablets in the Treatment of Obstructive Hypertrophic Cardiomyopathy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Age 18-85 years old, gender unlimited.
• BMI\<35 kg/m2.
• The diagnosis was obstructive hypertrophic cardiomyopathy.
• Laboratory determination of echocardiography showed that Rest LVOT-G≥50 mmHg, or Rest LVOT-G≥30 mmHg and LVOT-G≥50 mmHg after Valsalva action.
• Echocardiographic laboratory tests showed LVEF≥60%.
• NYHA classification: Grade II - III.
• Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.
Locations
Other Locations
China
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Beijing
Contact Information
Primary
Yun Jin
yun.jin.yj1@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2026-11
Participants
Target number of participants: 216
Treatments
Experimental: HRS-1893 Group
Placebo_comparator: HRS-1893 Placebo Group
Related Therapeutic Areas
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.