A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM).
Had a history of severe valvular heart disease.
Abnormal laboratory test results during screening, or any other clinically significant abnormal screening laboratory values, which are determined by the researcher to be unsuitable for inclusion.
Other circumstances where the researchers consider the subjects unsuitable to participate in this trial, such as physical or mental illnesses or conditions that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.
Trial design
Treatments tested in this trial
- HRS-1893 Tablets
- HRS-1893 Placebo Tablets
Treatment groups
216 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov