Efficacy and Safety Study of F373280

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Pierre Fabre Medicament
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01831856
First received: April 11, 2013
Last updated: September 2, 2014
Last verified: November 2013

April 11, 2013
September 2, 2014
April 2013
April 2016   (final data collection date for primary outcome measure)
First Atrial Fibrillation recurrence [ Time Frame: Up to 20 weeks after electrical cardioversion ] [ Designated as safety issue: No ]
Time to first Atrial Fibrillation recurrence defined by the first episode of Atrial Fibrillation lasting for at least 10 minutes
Same as current
Complete list of historical versions of study NCT01831856 on ClinicalTrials.gov Archive Site
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Not Provided
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Efficacy and Safety Study of F373280
Efficacy and Safety Study of F373280 for Maintenance of Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation and Chronic Heart Failure. International, Multicentric, Randomised, Double-blind, Placebo Controlled Study.

The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal cardiac rhythm after direct electric cardioversion in patients with persistent atrial fibrillation and cardiac failure.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: 1g of F373280
    Oral administration, one capsule each evening with dinner.
  • Drug: Placebo
    Oral administration, one capsule each evening with dinner.
  • Experimental: F373280
    Intervention: Drug: 1g of F373280
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
April 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or women aged more than 18 years (inclusive),
  • Patients with persistent Atrial Fibrillation between 7 days and 6 months duration for whom electrical cardioversion is warranted.
  • History of ischemic or non ischemic heart failure
  • On appropriate, stable medical treatments for heart failure, including a diuretic and/or angiotensin-converting enzyme, and/or angiotensin-receptor blocker and/or mineralocorticoid receptor (MR) antagonists, and/or betablockers
  • Patients treated or having to be treated by anti-vitamin K

Exclusion Criteria:

  • More than two successful cardioversions (electrical or pharmacological) in the last 6 months
  • Secondary Atrial Fibrillation due to alcohol or severe valvular heart disease (grade III to IV)
  • Thyroid disease uncontrolled by treatment
  • Myocardial infarction or unstable angina or presence of unstable ischemic coronaropathy assessed by coronarography or cardiac stress test within 6 months before selection
  • Severe chronic kidney disease at selection
  • Bradycardia
  • Hyperkalemia or hypokalemia at selection
  • Cardiac surgery within 3 months before selection or planned during the study duration
  • Previously ineffective pharmacological or electrical cardioversion
  • Concomitant treatment with any anti-arrhythmic drug (within 7 days prior to selection), except stable dose of digoxin, betablockers, calcium-blockers
  • Patient requiring a cardiac resynchronization therapy (CRT) or having undergone CRT implantation within the last 6 months
  • Treatment with any Polyunsaturated Fatty Acid (PUFA) within the last 3 months
  • Dietary supplement with ω3 or ω6 according to investigator's judgement
  • Having undergone any form of ablation therapy for Atrial Fibrillation
  • Patient treated with other anticoagulant treatment than antivitamin K: thrombin inhibitor such as Dabigatran or treated with antiaggregant P2Y12 inhibitors such as Clopidogrel or Prasugrel
  • Patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion
  • Breast-feeding female patient
Both
18 Years and older
No
Contact: Pierre FABRE MEDICAMENT contact_cop@pierre-fabre.com
Czech Republic,   France,   Hungary,   Italy,   Poland,   Spain
 
NCT01831856
F373280 CA 2 01, 2012-003487-48
Not Provided
Pierre Fabre Medicament
Pierre Fabre Medicament
Not Provided
Not Provided
Pierre Fabre Medicament
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP