A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary Efficacy Study of K201 Oral for the Prevention of Atrial Fibrillation (AF) Recurrence in Subjects Post-Conversion from AF - ARCTIC-AF

Sequel Pharmaceuticals, Inc.0 sites300 target enrollmentStarted: February 24, 2010Last updated: January 6, 2015

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: Sequel Pharmaceuticals, Inc.
Enrollment: 300

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. Comprehend and sign a written informed consent form, (per local and national regulations, as applicable)
•2. Age of 18 years or more.
•3. Women must not be pregnant, be non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until the two week follow-up visit after the last dose of medication. Methods of birth control considered to be effective are hormonal anticonception; birth control pill, implant, transdermal depot adhesive, vaginal ring or depot injection), an intrauterine device (IUD), or sterilization. Men should be advised not to conceive a child and are advised to use an effective form of birth control from admission until the two week follow-up visit after the last dose of study medication
•4. Have symptomatic AF that has been sustained for greater than 3 days (72 hours) and less than 180 days (6 months) duration and is clinically indicated for cardioversion; subjects may have a mix of AF and atrial flutter if AF is predominant and was the presenting arrhythmia.
•5. Have adequate anticoagulant therapy for cardioversion in accordance standard of practice as recommended by ACC/AHA/ESC guidelines 8 or with local clinical practice (e.g. TEE algorithm);
•6. Be hemodynamically stable (90 mmHg < systolic blood pressure < 190 mmHg) at screening and on Day 1 before dosing (while taking rate control drugs, if required).
•7. Subject has a Body Mass Index (BMI) < 35.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•1. At screening, have known prolonged QT syndrome, familial Long QT syndrome, QTcF interval of >500 msec as measured on a 12-lead ECG while in AF; previous history of Torsade de Pointes, ventricular fibrillation, or sustained ventricular tachycardia (VT); After DC cardioversion and while in sinus rhythm, QTcF >440/450 ms for males/females, respectively.
•2. Have a QRS >0.130 sec.
•3. Previous episodes of second or third-degree atrioventricular block.
•4. Last DC cardioversion attempt occurred within 3 months and was unsuccessful (including IRAF); or any prior ablation for AF.5. Have persistent bradycardia with ventricular rate below 50 beats/min that in the opinion of the investigator is clinically significant, sick-sinus syndrome or pacemaker (including CRT, AICD).Have persistent tachycardia greater than 110 beats/min.
•6. Have clinically significant moderate or severe valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis.
•7.Have NYHA Class III or Class IV heart failure (HF) at screening or admission, have been hospitalized with HF or new diagnosis of HF in the previous 6 months; any change in HF medications within 2 months; NT-proBNP > 47 pmol/L; EF < 45% obtained within two weeks prior to cardioversion.
•8. Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study; Have serious pulmonary, hepatic (i.e. ALT >3X ULN), metabolic, renal (i.e. eGFR < 30mL/min), gastrointestinal, central nervous system (i.e. stroke or TIA within past 6 months) or psychiatric disease (e.g. drug addiction or alcohol dependence), end-stage disease states, or any other disease that in the opinion of the investigator could interfere with the conduct or validity of the study or compromise subject safety.
•9. Have known concurrent temporary secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation < 90% on room air), acute pericarditis, or myocarditis.
•10. Hypokalemia (K+ should be corrected prior to dosing).
•11. Have clinical evidence of digoxin toxicity.
•12. Have received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks.
•13. Have received treatment with other drugs known to prolong the QT interval within 5 half-lives, including, certain antidepressants (e.g. tricyclic antidepressants), certain antihistaminics (e.g. terfenadine, astemizole), certain antiinfectives (e.g. erythromycin), certain antipsychotics (e.g. haloperidol, pimozide, thioridazine, ziprasidone); certain cardiovascular non-antiarrhythmics (e.g. bepridil), certain gastro-intestinal agents (e.g. cisapride).
•14. Have any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons.
•15. Be concurrently participating in another investigational drug study or have received an investigational drug within 30 days or 5 half-lives prior to screening.
•16. Be unable to communicate well with the Investigator and to comply with the requirements of the entire study.
•17. Have received potent CYP2D6 or CYP3A inhibitors within 5 half-lives. Potent CYP2D6 include bupropion, fluoxetine, paroxetine, cinacalcet and quinidine. Potent CYP3A inhibitors include indinavir, nelfinavir, ritonavir, saquinavir, clarith

Investigators

Sponsor

Sequel Pharmaceuticals, Inc.

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