Phase 2 Study of Oral K201 for Prevention of AF Recurrence (ARCTIC-AF)
This study has been terminated.
Sponsor:
Sequel Pharmaceuticals, Inc
Information provided by:
Sequel Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01067833
First received: February 10, 2010
Last updated: May 13, 2011
Last verified: May 2011
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Purpose
To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration >3 days and <6 months).
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: K201 Tablet Drug: Placebo Tablet |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Brugada syndrome
familial atrial fibrillation
short QT syndrome
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Sequel Pharmaceuticals, Inc:
Primary Outcome Measures:
- time to first documented recurrence of symptomatic AF [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- time to first documented recurrence of symptomatic or asymptomatic AF [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- proportion of subjects in sinus rhythm [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
- number of AF beats [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- time in AF [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo Tablet
oral tablet, x28 days
|
|
Experimental: Dose 1
K201
|
Drug: K201 Tablet
oral tablet, x28 days
|
|
Experimental: Dose 2
K201
|
Drug: K201 Tablet
oral tablet, x28 days
|
|
Experimental: Dose 3
K201
|
Drug: K201 Tablet
oral tablet, x28 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Symptomatic AF (sustained >3 days and <6 months) and clinically indicated for cardioversion;
- Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice;
- Hemodynamically stable (90 mmHg < systolic blood pressure < 190 mmHg)at screening and on Day 1;
Exclusion Criteria:
- Known prolonged QT syndrome or QTc interval of >0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT);
- QRS >0.130 sec;
- Previous episodes of second- or third-degree atrioventricular block;
- Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF;
- Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD);
- Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
- NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months;
- Known concurrent temporary secondary causes of AF;
- Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
- Received treatment with other drugs known to prolong the QT interval within 5 half-lives.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Howard C. Dittrich, CMO, Sequel Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT01067833 History of Changes |
| Other Study ID Numbers: | CJO-201 |
| Study First Received: | February 10, 2010 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Food and Drug Administration Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Sweden: Medical Products Agency Norway: Norwegian Medicines Agency |
Keywords provided by Sequel Pharmaceuticals, Inc:
|
atrial fibrillation AF |
Additional relevant MeSH terms:
|
Atrial Fibrillation Recurrence Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on October 17, 2012
