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This is a open label randomized, multi-center study conducted in Taiwan. The study aims to evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the conversion of paroxysmal AF and is designed to evaluate the improvement in sinus rhythm restoration after the treatment with Rhynorm (A drug) and Rytmonorm (B drug) for 24 weeks.
This is a open label randomized, multi-center study conducted in Taiwan. The study aims to evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the conversion of paroxysmal AF and is designed to evaluate the improvement in sinus rhythm restoration after the treatment with Rhynorm (A drug) and Rytmonorm (B drug) for 24 weeks.
This study comprised of three phases: a screening phase, a washout run-in qualifying phase lasting about 7 days, and a treatment phase of 24 weeks. A total of 60 evaluable subjects is planned to be enrolled. With an estimation of 20% dropout rate, 72 patients will be enrolled to reach 60 evaluable patients at the end of study. After screening for eligibility, the eligible subjects will be randomly assigned to either of the two gruop. The two-group are shown in the following table.
Group Treatment Drug Group A Rhynorm (A drug) Group B Rytmonorm (B drug) Patients with arrhythmia will be screened for eligibility after providing informed consent. Patients present with the symptoms of arrhythmia after withdrawn from other prohibited anti-AF agents for at least 7 days and completed run-in period event recorded will be qualified for entering this study and will be randomized to Rhynorm (A drug) treatment group or Rytmonorm (B drug) reference drud group in a 1:1 ratio.
The clinical evaluation will be recorded during the study period. Before treating with Rhynorm (A drug) and Rytmonorm (B drug), the physical examination and condition will be tracked and recorded for at least 7 days as the historical data.
During the treatment period, the subjects still had a routine OPD visit. Record symptom event and event recorder monitoring on OPD visit.
Safety assessments on all randomized subjects include adverse events, vital signs, and laboratory tests (hematology and biochemistry). Any adverse events, symptom events and concomitant medications/therapies will be recorded on the CRFs throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A drug | Experimental | Rhynorm(A drug) |
|
| B drug | Active Comparator | Rytmonorm (B drug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propafenone | Drug | oral, TID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with recurrent AF | To compare the effect of Rhynorm (A drug) and Rytmonorm (B drug) over 24 weeks of treatment based on the proportion of patients with recurrent AF | 24 weeks treatment |
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Inclusion Criteria:
Patients who are 20~80 years of age
Recurrent AF patients
Patients with paroxysmal atrial fibrillation
Patients diagnosed with one of the ECG monitoring within 12 months prior screening visit:
Patient may be receiving stable dose of propafenone since at least 4 weeks prior screening visit.
Agree to and are able to follow the study procedures
Understand the nature of the study, and have signed informed consent forms
Exclusion Criteria:
Permanent or persistent AF
Any of the following heart disease:
Symptomatic Bradycardia (heart rate less than 50 beats per minute)
Hemodynamic instability, defined as hypotension (SBP < 90 mm Hg)
Hyperthyroidism
Bronchospastic disorders or severe obstructive pulmonary disease
Correctable AF for other reasons
Marked electrolyte imbalance
Patients with clinically significant abnormalities in the following laboratory parameters:
Patients with known contraindication or history of allergy to Propafenone.
Female patients who are pregnant or lactating.
Female patients of child-bearing potentiality who do not agree to use an effective method of contraception during the study
Patients currently participating in any drug related clinical trial within 30 days
Patients with propagating factor (e.g. Alcohol Abuse induced AF)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36800262 | Derived | Chin CG, Hsieh YC, Lin WS, Lin YJ, Chiou CW, Lin TH, Huang CL, Hung Y, Lin YK, Chang SL, Yeh TC, Lee HC, Lai WT, Hsieh MH. An open-label randomized noninferior study of generic name and brand name of propafenone for rhythm control in patients with paroxysmal atrial fibrillation. J Chin Med Assoc. 2023 May 1;86(5):472-478. doi: 10.1097/JCMA.0000000000000903. Epub 2023 Feb 17. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011405 | Propafenone |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)
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| D013568 |
| Pathological Conditions, Signs and Symptoms |