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To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation

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Meda Pharmaceuticals

Status and phase

Completed
Phase 4

Conditions

Atrial Fibrillation

Treatments

Drug: Flecainide controlled release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00189319
1478-FLEC

Details and patient eligibility

About

The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • In sinus rhythm at treatment initiation
  • Experienced symptomatic AF episodes
  • Left ventricular ejection fraction of at least 40%
  • Females of child bearing potential must be using reliable method of contraception

Exclusion criteria

  • Intolerance and/or failure of previous therapy with flecainide immediate release
  • Currently receiving >200mg/day flecainide immediate release
  • Severe symptoms during episodes of arrhythmia
  • History of other cardiac conditions/abnormalities
  • Heart surgery within the last 2 months
  • Renal failure
  • Pregnant or lactating females
  • Significant extra cardiac or systemic disease
  • Abnormal electrolyte levels
  • Receiving defined cardiac and/or other treatments

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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