NCT06949020

CompletedPhase 2

A Dose-finding Study of JMKX003142 in Treatment of Cardiac E...

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Other study identifiers

Sponsor study identifier

JMKX003142-H201

Study Type

interventional

Actual enrollment (reported)

160

Locations

1 country

Sites

1

Timeline

Study Start

July 9, 2025

Actual (reported)

Primary Completion

March 14, 2026

Actual (reported)

Study Completion

April 26, 2026

Actual (reported)

Brief Summary

To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 160 participants
Study completion date: April 26, 2026
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 22, 2025
Actual (reported)
First Posted
April 29, 2025
Actual (reported)
Study Start
July 9, 2025
Actual (reported)
Primary Completion
March 14, 2026
Actual (reported)
Study Completion
April 26, 2026
Actual (reported)

Last Updated: August 6, 2026
Status Verified: August 2026
Last Update Submitted: August 4, 2026

Conditions

Cardiac Edema

Keywords

fluid retentionheart failure

Outcome Measures

Primary Outcomes (1)

body weight
5 days

Study Arms (4)

low dose group

EXPERIMENTAL

Drug: JMKX003142 Injection

median dose group

EXPERIMENTAL

Drug: JMKX003142 Injection

high dose group

EXPERIMENTAL

Drug: JMKX003142 Injection

placebo group

PLACEBO COMPARATOR

Interventions

JMKX003142 InjectionDrug

JMKX003142 injection for experimental groups once daily for five days.

high dose group

JMKX003142 InjectionDrug

JMKX003142 injection for experimental groups once daily for five days.

low dose group

Eligibility Criteria

Age18 Years+

Sexall(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;

Sponsors & Collaborators

Jemincare
Industrylead

Study Sites (1)

The Second Affiliated Hospital,School of Medicine,Zhejiang University

Hangzhou, Zhejiang, 310009, China

MeSH Terms

Conditions

Edema, CardiacHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesEdemaSigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

160 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 29, 2025

Study Start

July 9, 2025

Actual (reported)

NCT00544869

A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)

Phase 3Completed

Drug: JMKX003142 placebo

JMKX003142 InjectionDrug

JMKX003142 injection for experimental groups once daily for five days.

median dose group

JMKX003142 placeboDrug

JMKX003142 placebo for placebo groups once daily for five days.

placebo group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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;

The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period:

\) At least 40mg/day of furosemide equivalent loop diuretics; 2) Any dose of loop diuretics combined with thiazide diuretics; 3) Any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics.

\. After the background treatment in the run-in period, the subject still has the following two conditions:

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;

During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.

You may not qualify if:

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);
Subjects with hypovolemia or suspected hypovolemia;
Subject cannot feel thirst or have difficulty in fluid intake during screening;
During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;
Administered with tolvaptan 14days before randomization ；
Pregnancy (female pregnancy test positive) or lactation period;

Contact the study team to confirm eligibility.

Primary Completion

March 14, 2026

Actual (reported)

Study Completion

April 26, 2026

Actual (reported)

Last Updated

August 6, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06949020
Data provider: ClinicalTrials.gov
Source updated: 2026-08-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:06 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

low dose group

median dose group

high dose group

placebo group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations