A Phase 2 interventional study of K201 Tablet and Placebo Tablet in Atrial Fibrillation, sponsored by Sequel Pharmaceuticals, Inc. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-16.
Sponsored by Sequel Pharmaceuticals, Inc · Phase 2, Interventional, and Prevention
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).
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 300 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Sequel Pharmaceuticals, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Placebo
Drug: Placebo Tablet
K201
Drug: K201 Tablet
K201
Drug: K201 Tablet
K201
Drug: K201 Tablet
oral tablet, x28 days
oral tablet, x28 days
time to first documented recurrence of symptomatic AF
Time frame: 28 days
time to first documented recurrence of symptomatic or asymptomatic AF
Time frame: 28 days
proportion of subjects in sinus rhythm
Time frame: Day 28
number of AF beats
Time frame: 10 days
time in AF
Time frame: 10 days
safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events
Time frame: 42 days
No study locations are listed for this record.
The record gives a start of Apr 2010, a primary completion of Oct 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: K201 compound
Sequel Pharmaceuticals, Inc