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Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure

NCT04468529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-07-25

No results posted yet for this study

Summary

A multi-center, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the effect of injectable Neucardin on the heart function in male patients with NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml, NYHA II-III chronic systolic heart failure, and to confirm its efficacy and safety.

Conditions

  • Chronic Systolic Heart Failure

Interventions

DRUG

Recombinant human Neuregulin for injection

10 hours per day i.v. drip for the first 10 days (0.6ug/kg/day)

DRUG

Placebo

10 hours per day i.v. drip for the first 10 days (0ug/kg/day)

Sponsors & Collaborators

  • Zensun Sci. & Tech. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xinchun Yang, M.D · Beijing Chao Yang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2022-04-12
Completion
2024-04-07

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468529 on ClinicalTrials.gov