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Fluoroquinolone Antibiotic

Moxifloxacin for Cardiac Toxicity

Phase 1
Waitlist Available
Led By Haiyan Li, MD
Research Sponsored by Haiyan Li
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

Study Summary

A double-center, randomized, double-blinded, 2-way crossover, placebo-controlled Study: Comparison of single oral dose 400mg Moxifloxacin-induced QT prolongation between healthy Chinese volunteers and Caucasian Volunteers Study Objective:Primary Objective:To compare the difference of ΔΔQTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Chinese group and Caucasian group under the same exposure (Cmax) of Moxifloxacin.Secondary Objectives:1)To compare the difference of ΔΔQTcF, heart rate, PR, RR, QRS and Moxifloxacin plasma concentration between Chinese group and Caucasian group.2)To compare slopes of Moxifloxacin plasma Concentration/QTcF value between healthy Chinese volunteers and Caucasian Volunteers.

Eligible Conditions
  • Cardiac Toxicity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ΔΔQTcF

Side effects data

From 2008 Phase 2 trial • 170 Patients • NCT00082173
4%
Hospitalization
4%
Death
1%
Grade 4 event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental Arm
Control Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MoxifloxacinExperimental Treatment1 Intervention
Single oral dose 400 mg
Group II: PlaceboPlacebo Group1 Intervention
Single oral dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moxifloxacin
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Peking UniversityOTHER
436 Previous Clinical Trials
1,053,178 Total Patients Enrolled
BioClinica, Inc.Industry Sponsor
7 Previous Clinical Trials
2,938 Total Patients Enrolled
Haiyan LiLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Race Difference Moxifloxacin-induced QT Prolongation Between Healthy Chinese and Caucasian Volunteers
Haiyan Li 2014. "Race Difference Moxifloxacin-induced QT Prolongation Between Healthy Chinese and Caucasian Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02119091.
All > Health
~7 spots leftby May 2025
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