A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema
ConditionCardiac Edema
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare
About this trial
To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;
Age ≥ 18 years old when signing the informed consent form;
At the screening stage, it has been definitely diagnosed as heart failure, and it is combined with one of the following clinical manifestations related to body fluid retention: edema of both lower limbs, jugular vein engorgement, pulmonary congestion;
One of the following clinical manifestations related to fluid retention still exists after the induction phase treatment: edema of both lower limbs, jugular vein dilatation, pulmonary congestion;
Disqualifiers
Edema caused by diseases other than heart failure；
Subjects with ventricular assist devices during screening;
Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;
Acute myocardial infarction occurred within 30 days prior to screening; subjects with a history of persistent ventricular tachycardia or ventricular fibrillation within the 30 days prior to screening (those without implantable defibrillators); History of cerebrovascular disease within 6 months prior to screening (excluding asymptomatic cerebral infarction);
Trial design
Design model
Parallel
Treatments tested in this trial
JMKX003142 Injection
DrugJMKX003142 injection for experimental groups once daily for five days.
JMKX003142 Injection
DrugJMKX003142 injection for experimental groups once daily for five days.
JMKX003142 Injection
DrugJMKX003142 injection for experimental groups once daily for five days.
JMKX003142 placebo
DrugJMKX003142 placebo for placebo groups once daily for five days.
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: low dose groupExperimental treatment 1 intervention
Group B: median dose groupExperimental treatment 1 intervention
Group C: high dose groupExperimental treatment 1 intervention
Group D: placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
body weight
Time frame
5 daysLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: