Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
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|ClinicalTrials.gov Identifier: NCT01235156|
Recruitment Status : Unknown
Verified November 2010 by Jiangsu Furui Pharmaceuticals Co., Ltd.
Recruitment status was: Recruiting
First Posted : November 5, 2010
Last Update Posted : November 5, 2010
|Condition or disease|
|Premature Ventricular Contraction|
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).
|Study Type :||Observational|
|Estimated Enrollment :||36 participants|
|Observational Model:||Case Control|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235156
|Beijing chao-yang hosipital||Recruiting|
|Beijing, Beijing, China, 100020|
|Contact: Gao M Ming, doctor 8610-010-85231936 email@example.com|
|Contact: Liu J Mei, doctor 8610-010-85231936 firstname.lastname@example.org|
|Principal Investigator: Yang Xin Chun, doctor|
|Peking university people's hosipital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: zhang Ping, doctor 0086-010-88325264 email@example.com|
|Contact: Li Chun, doctor 0086-010-88325264 firstname.lastname@example.org|
|Principal Investigator: Guo Ji Hong, doctor|