Premature Ventricular Contraction Clinical Trial
Official title:
A Single-dose, Open Labeled, Multicenter Phase IIa Clinical Study on the Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
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).
Arrhythmia is a common disease that may be caused by various cardiovascular diseases. The
incident rate of various types of arrhythmias may be as high as 86-100% in patients who
experience acute myocardial infarction within 10 days. Serious arrhythmias can endanger
lives instantly. According to statistics, 500,000 people die of severe arrhythmia every year
in China, which constitutes approximately 50% of the death rate for cardiovascular diseases.
In the United States, among 1,500,000 myocardial infarction patients, approximately 540,000
patients die each year, which is mainly caused by ventricular fibrillation (VF) and sudden
cardiac death (SCD).
Initially at least 24 subjects who meet the inclusion criteria and do not meet the exclusion
criteria will be enrolled into either of two dose levels under a 3:1 randomization
(active:placebo) take sulcardine sulfate tablets.Dose levels may be dropped, an intermediate
dose level added as needed to deemed appropriate following review of safety and tolerability
data at the prior dose level(200mg,400mg). A safety review committee will review data from
all enrolled subjects at the simultaneous completion of Dosing Cohort 1 and 2 prior to
advancement to the final dose level (800mg BID).
;
Observational Model: Case Control, Time Perspective: Cross-Sectional
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