Atrial Premature BeatsPhase 4NCT02319603
To Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats
A Phase 4 study testing Low dose WenXin keli and High dose WenXin keli in people with Atrial Premature Beats, run by Beijing Bozhiyin T&S Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Premature Beats
- What is being tested?
- Low dose WenXin keli and High dose WenXin keli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Feb 2017
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Need to merge other anti-arrhythmic drugs(Ⅰ,Ⅱ,Ⅲ,Ⅳ) 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 Ⅱdegree 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Jihong Guo, doctor contact
China1 site, 1 recruiting
- Recruiting
Peking University people's hospital
Beijing, Beijing Municipality, 100044
duan jingbo, visiting staff, 18612189012, duanjiangbopku@126.com
About this study
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.
Read the detailed description
Research purpose： 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.
Research design： A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial.
Sample size:
A total of 288 subjects, 144cases in each group.
Therapeutic schedule:
- Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.
- High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.
Usage and Dosage:
Oral ,1bag each time, 3 times a day, 4 weeks for 1 course of treatment.
Drug combination:
During the test shall not merge the other anti-arrhythmic drugs beyond the provisions of this scheme. Due to merger disease or condition changes ,have to use drugs or other treatment, investigators must record the types (or other treatment ),drug usage, time and reasons, in order to summarize ,analyze and report.
Primary indicator:
24 h dynamic electrocardiogram (Holter): before treatment, after treatment of 4 w, each record at a time.
Secondary Indicator:
Symptom scores: before treatment, after treatment of 4 w, each record at a time.
Security index:
- Vital signs: before treatment, after treatment of 4 w, each record at a time.
- Blood, urine, stool occult blood ,liver and kidney function, blood coagulation four, electrolyte examination, electrocardiogram(ecg): before treatment, after treatment of 4 w, each record at a time.
Main efficacy:
Holter efficient curative effect (main efficacy index) Effective: premature beat frequency reduced 50% or more before taking the medicine.
Invalid: no effective standard.
Secondary efficacy:
Symptom scores curative effect Effective:symptoms improve symptoms(drop 1or above) Invalid: no effective standard.
Statistic analysis:
Main efficacy index by means of FAS,PPS analysis ,safety index SS set analysis.
- Conditions
- Atrial Premature Beats
- Being tested
- Low dose WenXin keli, High dose WenXin keli
- Medical subject headings
- Atrial Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose WenXin keliDrug
Also called the original quantity Wenxin keli
Low dose WenXin keli (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.
High dose WenXin keliDrug
Also called 2 times the amount of Wenxin keli
High dose WenXin keli(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.
| Study group | Role | What they receive |
|---|---|---|
| Low dose WenXin keli | Active comparator | Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.
Oral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment. Receives: Drug: Low dose WenXin keli |
| High dose WenXin keli | Experimental | High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.
Oral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment. Receives: Drug: High dose WenXin keli |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 h dynamic electrocardiogram (Holter)
Baseline, up to 4 weeks, each record at a time.
Measured: Baseline, up to 4 weeks, each record at a time.
Secondary outcomes (1)
Symptom scores
Baseline, up to 4 weeks, each record at a time.
Measured: Baseline, up to 4 weeks, each record at a time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Premature BeatsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Bozhiyin T&S Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihong Guo, doctor, Principal investigator, Director of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319603
- Sponsor's protocol ID
- WX-20141022
- Status last verified
- Jul 2015
- First submitted
- 2 Dec 2014
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02319603
- Acronym / sponsor ID
- WX-20141022
- Conditions
- Atrial Premature Beats
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Beijing Bozhiyin T&S Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 18 Dec 2014 (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.
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.
Detailed description
Research purpose： 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.
Research design： A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial.
Sample size:
A total of 288 subjects, 144cases in each group.
Therapeutic schedule:
- Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.
- High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.
Usage and Dosage:
Oral ,1bag each time, 3 times a day, 4 weeks for 1 course of treatment.
Drug combination:
During the test shall not merge the other anti-arrhythmic drugs beyond the provisions of this scheme. Due to merger disease or condition changes ,have to use drugs or other treatment, investigators must record the types (or other treatment ),drug usage, time and reasons, in order to summarize ,analyze and report.
Primary indicator:
24 h dynamic electrocardiogram (Holter): before treatment, after treatment of 4 w, each record at a time.
Secondary Indicator:
Symptom scores: before treatment, after treatment of 4 w, each record at a time.
Security index:
- Vital signs: before treatment, after treatment of 4 w, each record at a time.
- Blood, urine, stool occult blood ,liver and kidney function, blood coagulation four, electrolyte examination, electrocardiogram(ecg): before treatment, after treatment of 4 w, each record at a time.
Main efficacy:
Holter efficient curative effect (main efficacy index) Effective: premature beat frequency reduced 50% or more before taking the medicine.
Invalid: no effective standard.
Secondary efficacy:
Symptom scores curative effect Effective:symptoms improve symptoms(drop 1or above) Invalid: no effective standard.
Statistic analysis:
Main efficacy index by means of FAS,PPS analysis ,safety index SS set analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose WenXin keli | Active comparator | Drug: Low dose WenXin keliLow dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g. Oral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment. |
| High dose WenXin keli | Experimental | Drug: High dose WenXin keliHigh dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g. Oral ,1 bag each time, 3 times a day, 4 weeks for 1 course of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Need to merge other anti-arrhythmic drugs(Ⅰ,Ⅱ,Ⅲ,Ⅳ) 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 Ⅱdegree atrioventricular block)
- Patients have had heart percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) surgery
- Patients with severe hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose WenXin keliAlso: the original quantity Wenxin keliLow dose WenXin keli (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g. | Drug | Low dose WenXin keli |
| High dose WenXin keliAlso: 2 times the amount of Wenxin keliHigh dose WenXin keli(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g. | Drug | High dose WenXin keli |
Primary outcome
24 h dynamic electrocardiogram (Holter)
Time frame: Baseline, up to 4 weeks, each record at a time.
Baseline, up to 4 weeks, each record at a time.
1 secondary outcome
Symptom scores
Time frame: Baseline, up to 4 weeks, each record at a time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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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.
Jihong Guo, doctor contact
Jihong Guo, doctor principal investigator
Director of department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low dose WenXin keli and High dose WenXin keli in people with Atrial Premature Beats, run by Beijing Bozhiyin T&S Co., Ltd. at 1 site 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 11 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jihong Guo, doctor (13901148380), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 h dynamic electrocardiogram (Holter) (time frame: Baseline, up to 4 weeks, each record at a time.). It is what the study was designed to measure, not a finding.
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 23 Jul 2015.