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Status unknownNCT01235156Updated Nov 5, 2010

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

An observational study in Premature Ventricular Contraction, sponsored by Jiangsu Furui Pharmaceuticals Co., Ltd. Status unknown at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-11-05.

Sponsored by Jiangsu Furui Pharmaceuticals Co., Ltd · Observational

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
36
Ages
18 Years to 70 Years
Sex
All
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Study 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).

Read the 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).

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Conditions studied

  • Premature Ventricular Contraction

Keywords

  • Premature ventricular contraction
  • Frequent premature ventricular contraction, with or without a short array of non-sustained ventricular tachycardia
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In context

Ventricular Premature Complexes

96 studies on the registry are indexed under Ventricular Premature Complexes; 29 are open to participants now.

This study's planned enrollment of 36 is below the median of 113 across 36 observational studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

This is the only study on the registry with Jiangsu Furui Pharmaceuticals Co., Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
36 participants (estimated)
06

Study locations

2 of 2 sites recruiting
  • Beijing chao-yang hosipital
    Beijing, Beijing Municipality 100020, China
    Recruiting
  • Peking university people's hosipital
    Beijing, Beijing Municipality 100044, China
    Recruiting
    • zhang Ping, doctor · Contactzhp1024@263.net · 0086-010-88325264
    • Li Chun, doctor · Contactyxh9956@vip.sina.com · 0086-010-88325264
    • Guo Ji Hong, doctor · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01235156
Lead sponsor
Jiangsu Furui Pharmaceuticals Co., Ltd
First posted
Nov 5, 2010
Start date
Nov 2010
Last update
Nov 5, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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