A Multicenter, Open-Label, Dose Escalation Study of the Safety, Tolerability, and Efficacy of Budiodarone for the Treatment of Subjects with Non-permanent Atrial Fibrillation

Conditions

Non-permanent Atrial Fibrillation

Brief summary

Safety: • Incidence of TEAE and treatment-emergent serious adverse events (TESAE). • Incidence of AESI • Mortality and Clinical Morbidity Events: o Death o Resuscitated sudden cardiac death (SCD) including appropriate implanted cardiac defibrillator (ICD) discharge o Cardiovascular hospitalization o Stroke or another thromboembolic event • Physical Exam assessments and abnormalities. • Vital sign assessments and abnormalities. • Clinical laboratory assessment and abnormalities. o Thyroid functio, Primary Efficacy: • Proportion of participants that have no LEAF (uninterrupted episode of AF that is 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is greater than 5 hours) in the final month of treatment., Exploratory Endpoint: • The proportion of participants with no LEAF episodes lasting one hour or longer in the final month of budiodarone treatment

Detailed description

Secondary Efficacy: • Change in percent AFSS during final month of treatment compared to baseline for multiple doses of budiodarone. • PGI-C during the final month of treatment. • Percent change in AFB during final month of treatment compared to baseline.

Related papers

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Interventions

DRUGBUDIODARONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety: • Incidence of TEAE and treatment-emergent serious adverse events (TESAE). • Incidence of AESI • Mortality and Clinical Morbidity Events: o Death o Resuscitated sudden cardiac death (SCD) including appropriate implanted cardiac defibrillator (ICD) discharge o Cardiovascular hospitalization o Stroke or another thromboembolic event • Physical Exam assessments and abnormalities. • Vital sign assessments and abnormalities. • Clinical laboratory assessment and abnormalities. o Thyroid functio, Primary Efficacy: • Proportion of participants that have no LEAF (uninterrupted episode of AF that is 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is greater than 5 hours) in the final month of treatment., Exploratory Endpoint: • The proportion of participants with no LEAF episodes lasting one hour or longer in the final month of budiodarone treatment	—

Measure

Time frame

Safety: • Incidence of TEAE and treatment-emergent serious adverse events (TESAE). • Incidence of AESI • Mortality and Clinical Morbidity Events: o Death o Resuscitated sudden cardiac death (SCD) including appropriate implanted cardiac defibrillator (ICD) discharge o Cardiovascular hospitalization o Stroke or another thromboembolic event • Physical Exam assessments and abnormalities. • Vital sign assessments and abnormalities. • Clinical laboratory assessment and abnormalities. o Thyroid functio, Primary Efficacy: • Proportion of participants that have no LEAF (uninterrupted episode of AF that is 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is greater than 5 hours) in the final month of treatment., Exploratory Endpoint: • The proportion of participants with no LEAF episodes lasting one hour or longer in the final month of budiodarone treatment

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Secondary

Measure	Time frame
Secondary Efficacy: • Change in percent AFSS during final month of treatment compared to baseline for multiple doses of budiodarone. • PGI-C during the final month of treatment. • Percent change in AFB during final month of treatment compared to baseline.	—

Outcome results

None listed