Trial | NCT00626652  Report issue

Title

Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    k201 ...

  • Study Participants

    153
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
Study Started
Mar 31
2008
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Jan 08
2010
Estimate

Drug K201 Injection

single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule

1 Experimental

Criteria 

Inclusion Criteria:

Symptomatic atrial fibrillation
Atrial fibrillation documented by ECG
Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.

Exclusion Criteria:

Systolic blood pressure <100 mmHg
Heart rate <50 bpm
Temperature >38°C
QT or QTcB >440 ms
QRS >140 ms
Paced atrial or ventricular rhythm on ECG
Serum potassium <3.5 meq/L
History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
History of amiodarone in last 6 months.
Clinical evidence of acute coronary syndrome
Acute pulmonary edema or embolism
Hyperthyroidism
Acute pericarditis
History of failed electrical cardioversion at any time
History of torsades des pointes
History of familial long QT interval syndrome
History of ventricular tachycardia requiring drug or device therapy
History of NYHA Heart Failure Class 3 or 4.
No Results Posted