Health TrialsbyHealthPanel

A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy

ConditionObstructive 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS-1893 Tablets

    Drug

    HRS-1893 tablets.

  • HRS-1893 Placebo Tablets

    Drug

    HRS-1893 placebo tablets.

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: HRS-1893 GroupExperimental treatment 1 intervention
Group B: HRS-1893 Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The clinical response rate of treatment with HRS-1893.

Time frame
After 24 weeks of HRS-1893 treatment.

Secondary outcomes

1

The incidence of major adverse cardiac events (cardiovascular death, cardiac arrest, non-fatal stroke, non-fatal myocardial infarction, hospitalization for cardiovascular events).

Time frame
About 29 weeks.
2

Incidence and severity of any adverse events.

Time frame
About 29 weeks.
3

The change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) from the baseline.

Time frame
Week 12 and Week 24.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now