Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contract… (NCT01235156) | Clinical Trial Compass
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Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
China36 participantsStarted 2010-11
Plain-language summary
Arrhythmia is a common disease that may be caused by various cardiovascular diseases. According to statistics, 500,000 people die of severe arrhythmia every year in China, In the United States, approximately 540,000 patients die each year.This study will evaluate the effectiveness safety of sulcardine sulfate tablets in the patients with premature ventricular contractions (and non-sustained VT).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18-70 years old, body weight 45-80kg, and no sex preference.
✓. Frequent premature ventricular contraction, the total number of premature ventricular beats indicated by Holter monitor greater than 3600 over 24 hours, with or without a short array of non-sustained ventricular tachycardia (more than 3, but fewer than 10 consecutive ventricular beats).
✓. Negative pregnancy test result within 24 hours before the first dose for women of childbearing age. Females subjects of child bearing age must be on effective birth control (IUD or compliant use of oral contraceptive), have been surgically sterilized or abstain from sexual intercourse through the active dosing period and for the first 10 days after dosing.
✓. Voluntary participation in the study and the ability to complete the screening and trial procedures, and to remain in the clinical study site throughout dosing period in accordance with the protocol.
✓. Understand and voluntarily sign a written informed consent document.
Exclusion criteria
✕. History of Stage III-IV congestive heart failure.