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

NCT01235156 | Unknown DMC

• 1 other identifier: TG0823SUL
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Premature Ventricular Contraction

Keywords

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• History of Stage III-IV congestive heart failure.
• Ejection fraction \<35% predicted
• Polymorphic ventricular tachycardia, sustained ventricular tachycardia.
• Congenital or acquired long QT syndrome, Torsade de Pointes, or an uncorrected QT-interval of \>480 ms; QRS\>120 ms.
• Unstable angina, active myocarditis, rheumatic fever, or bacterial endocarditis, elevated Troponin T on work-up.
• Sinus node dysfunction, atrioventricular block above first degree not controlled by pacemaker.
• Complete left or right bundle branch block, or intraventricular block.
• Hypotension, sitting resting blood pressure below 90/55mmHg.
• Hypertension as defined by SBP\> 160mmHg and/or DBP \> 95mmHg
• Sinus bradycardia (average heart rate lower than 50 beats/min).
• Liver (liver function tests or bilirubin (direct or indirect) \>2XULN, history of cirrhosis or chronic active hepatitis.
• Kidney dysfunction (plasma creatinine\>1.8 and creatinine clearance calculation \<30 as determined by Cockroft-Gault calculation) or electrolyte or acid-base balance disorders.
• Taking digitalis, tricyclic antidepressants, β blockers, or calcium channel blockers within 5 half-lives for a given agent.
• Thyroid dysfunction.
• Serious respiratory diseases, Wolff-Parkinson-White syndrome; chronic obstructive pulmonary disease, asthma requiring medication

Sponsors & Collaborators

• Jiangsu Furui Pharmaceuticals Co., Ltd: lead

Study Sites (2)

Beijing chao-yang hosipital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Peking university people's hosipital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Study Start: November 1, 2010
• Last Updated: November 5, 2010

Record last verified: 2010-11

Locations

CN (2)