Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Jiangsu Furui Pharmaceuticals Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Jiangsu Furui Pharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier:
NCT01235156
First received: November 4, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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).


Condition Phase
Premature Ventricular Contraction
Phase 2

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Jiangsu Furui Pharmaceuticals Co., Ltd:

Estimated Enrollment: 36
Study Start Date: November 2010
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

18-70 year-old patients with premature ventricular contractions or non-sustained ventricular tachycardia (VT)

Criteria

Inclusion Criteria:

  1. Age 18-70 years old, body weight 45-80kg, and no sex preference.
  2. 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).
  3. 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.
  4. 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.
  5. Understand and voluntarily sign a written informed consent document.

Exclusion Criteria:

  1. History of Stage III-IV congestive heart failure.
  2. Ejection fraction <35% predicted
  3. Polymorphic ventricular tachycardia, sustained ventricular tachycardia.
  4. Congenital or acquired long QT syndrome, Torsade de Pointes, or an uncorrected QT-interval of >480 ms; QRS>120 ms.
  5. Unstable angina, active myocarditis, rheumatic fever, or bacterial endocarditis, elevated Troponin T on work-up.
  6. Sinus node dysfunction, atrioventricular block above first degree not controlled by pacemaker.
  7. Complete left or right bundle branch block, or intraventricular block.
  8. Hypotension, sitting resting blood pressure below 90/55mmHg.
  9. Hypertension as defined by SBP> 160mmHg and/or DBP > 95mmHg
  10. Sinus bradycardia (average heart rate lower than 50 beats/min).
  11. Liver (liver function tests or bilirubin (direct or indirect) >2XULN, history of cirrhosis or chronic active hepatitis.
  12. Kidney dysfunction (plasma creatinine>1.8 and creatinine clearance calculation <30 as determined by Cockroft-Gault calculation) or electrolyte or acid-base balance disorders.
  13. Taking digitalis, tricyclic antidepressants, β blockers, or calcium channel blockers within 5 half-lives for a given agent.
  14. Thyroid dysfunction.
  15. Serious respiratory diseases, Wolff-Parkinson-White syndrome; chronic obstructive pulmonary disease, asthma requiring medication
  16. Cyanotic or other uncorrected significant congenital heart disease.
  17. History of allergy to sulfonamides.
  18. Taking other anti-arrhythmic drugs or medications that affect cardiac electrophysiology, or stop taking the above mentioned medications less than 5 half-life of the drug ago.
  19. History of taking amiodarone within 1 years.
  20. Severe neurosis, menopausal syndrome, chest pain caused by cervical spondylosis.
  21. Diseases of the hematopoietic system, or mental illness.
  22. Current evidence of alcohol abuse or history of illegal drug abuse.
  23. Women of childbearing potential who are pregnant or nursing, or women of childbearing age who are not on effective birth control (IUD or compliant use of oral contraceptives and who have a positive urine pregnancy test prior to study.
  24. Participation in a clinical trial of other drugs within 3 months.
  25. Those considered not suitable to be selected by the investigators.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235156

Locations
China, Beijing
Peking university people's hosipital Recruiting
Beijing, Beijing, China, 100044
Contact: zhang Ping, doctor    0086-010-88325264    zhp1024@263.net   
Contact: Li Chun, doctor    0086-010-88325264    yxh9956@vip.sina.com   
Principal Investigator: Guo Ji Hong, doctor         
Beijing chao-yang hosipital Recruiting
Beijing, Beijing, China, 100020
Contact: Gao M Ming, doctor    8610-010-85231936    gaomingming168@vip.sina.com   
Contact: Liu J Mei, doctor    8610-010-85231936    liujiamei2006@163.com   
Principal Investigator: Yang Xin Chun, doctor         
Sponsors and Collaborators
Jiangsu Furui Pharmaceuticals Co., Ltd
  More Information

No publications provided

Responsible Party: 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, Jiangsu Furui Pharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier: NCT01235156     History of Changes
Other Study ID Numbers: TG0823SUL
Study First Received: November 4, 2010
Last Updated: November 4, 2010
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by Jiangsu Furui Pharmaceuticals Co., Ltd:
Premature ventricular contraction
Frequent premature ventricular contraction, with or without a short array of non-sustained ventricular tachycardia

Additional relevant MeSH terms:
Ventricular Premature Complexes
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014