Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
Recruitment status was: Recruiting
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|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|
|Study Start Date:||November 2010|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235156
|Beijing chao-yang hosipital|
|Beijing, Beijing, China, 100020|
|Peking university people's hosipital|
|Beijing, Beijing, China, 100044|