Premature Ventricular ContractionNCT01235156
Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
An observational study of Premature Ventricular Contraction, run by Jiangsu Furui Pharmaceuticals Co., Ltd at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Premature Ventricular Contraction
- How many people
- 36 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-70 year-old patients with premature ventricular contractions or non-sustained ventricular tachycardia (VT)
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- Cyanotic or other uncorrected significant congenital heart disease.
- History of allergy to sulfonamides.
- 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.
- History of taking amiodarone within 1 years.
- Severe neurosis, menopausal syndrome, chest pain caused by cervical spondylosis.
- Diseases of the hematopoietic system, or mental illness.
- Current evidence of alcohol abuse or history of illegal drug abuse.
- 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.
- Participation in a clinical trial of other drugs within 3 months.
- Those considered not suitable to be selected by the investigators.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing chao-yang hosipital
Beijing, Beijing Municipality, 100020
Gao M Ming, doctor, 8610-010-85231936, gaomingming168@vip.sina.com
Liu J Mei, doctor, 8610-010-85231936, liujiamei2006@163.com
- Recruiting
Peking university people's hosipital
Beijing, Beijing Municipality, 100044
zhang Ping, doctor, 0086-010-88325264, zhp1024@263.net
Li Chun, doctor, 0086-010-88325264, yxh9956@vip.sina.com
About this study
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
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).
- Conditions
- Premature Ventricular Contraction
- Keywords
- Premature ventricular contraction, Frequent premature ventricular contraction, with or without a short array of non-sustained ventricular tachycardia
- Medical subject headings
- Ventricular Premature Complexes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ContractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Furui Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235156
- Sponsor's protocol ID
- TG0823SUL
- Status last verified
- Nov 2010
- First submitted
- 4 Nov 2010
- Last updated
- 5 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01235156
- Acronym / sponsor ID
- TG0823SUL
- Conditions
- Premature Ventricular Contraction
- Keywords
- Premature ventricular contraction, Frequent premature ventricular contraction, with or without a short array of non-sustained ventricular tachycardia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jiangsu Furui Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-70 year-old patients with premature ventricular contractions or non-sustained ventricular tachycardia (VT)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ventricular Contraction, run by Jiangsu Furui Pharmaceuticals Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2010.