Atrial Premature Beats Clinical Trial
Official title:
A Randomized, Double-blind, Two Dose Group, Parallel-control Multi-center, Post-marketing Clinical Trial,to Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats.
A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.
| Status | Recruiting |
| Enrollment | 288 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Accord with the diagnostic criteria of arrhythmia (atrial premature beats ) - The average number of premature beat of 24 h dynamic electrocardiogram >360 times/h (effective record at least 22 h) - Stop using the anti- arrhythmic drugs for more than five half-life (except that who long-term (one month or more) with beta blockers for high blood pressure and exertional angina) - Ages 18 to 75 years old ,all genders - Voluntary subjects and signed the informed consent form Exclusion Criteria: - Need to merge other anti-arrhythmic drugs(?,?,?,?) for serious condition - Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders - Merge tardy arrhythmia (including sick sinus syndrome and ?degree atrioventricular block) - Patients have had heart percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) surgery - Patients with severe hypotension - With serious cardiovascular diseases (severe coronary heart disease, congenital heart disease, cardiomyopathy, myocardial infarction, congestive heart failure, cardiac shock, etc.), cerebrovascular disease, severe respiratory diseases (chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism, etc.),serious primary diseases such as liver, kidney and hematopoietic system (ALT,AST,BUN 2 times higher than normal ceiling, or Cr higher than the upper limit of normal) - Allergic constitution; the test drug allergy or its ingredients or elements allergy - Pregnancy and lactation women ,recent preparation pregnancy - With chronic alcoholism , drug dependence, mental illness - Participated in other clinical trials within 3 months - Patients thought by the investigators not suitable to participate in clinical trials |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Peking University people's hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Bozhiyin T&S Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 24 h dynamic electrocardiogram (Holter) | Baseline, up to 4 weeks, each record at a time. | Baseline, up to 4 weeks, each record at a time. | No |
| Secondary | Symptom scores | Baseline, up to 4 weeks, each record at a time. | Baseline, up to 4 weeks, each record at a time. | No |