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Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

NCT03875183 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-03-31

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose-response trial in patients with chronic stable Heart Failure (HF) and reduced Left Ventricular Ejection Fraction (LVEF) to evaluate the efficacy and safety of three INL1 doses compared with placebo. Patients will be treated for approximately 12 weeks with one of three INL1 doses: 50 mg, 150 mg, 300 mg, or, placebo capsules, taken twice daily (BID).

Conditions

Interventions

DRUG

INL1

Capsules

OTHER

Placebo

Capsules

Sponsors & Collaborators

  • Innolife Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Chen, MD · Innolife Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2022-12-31
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03875183 on ClinicalTrials.gov