Clinical trial NCT00526136 (phase 2, status: completed)
Conditions: atrial fibrillation
ICD codes: I48.0, I48.21, I48.91, I48.11, I48.19, I48.20
Drugs: placebo, vernakalant (oral)
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, COC1=C(OC)C=C(CCO[C@@H]2CCCC[C@H]2N2CC[C@@H](O)C2)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Comprehend and sign a written informed consent form, (per local and national
             regulations, as applicable)

          -  Be 18 to 85 years of age

          -  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 3 months after the last
             dose of medication. Methods of birth control considered to be effective may include
             hormonal contraception (the pill), an intrauterine device (IUD), condoms in
             combination with a spermicidal cream, total abstinence or sterilisation. Men should be
             advised not to conceive a child and are advised to use an effective form of birth
             control from admission until 3 months after the last dose of study medication

          -  Have symptomatic AF that has been sustained for greater than 72 hours and less than 6
             months duration and is clinically indicated for cardioversion;

          -  Have adequate anticoagulant therapy for cardioversion in accordance with standard of
             practice as recommended by ACC/AHA/ESC guidelines (Fuster V. et al, 2006);

          -  Be haemodynamically stable (100 mmHg < systolic blood pressure < 190 mmHg) at
             screening and on Day 1 before dosing (while taking rate control drugs, if required).
             After resting supine for 3 minutes, blood pressures should be measured 3 times in 5
             minutes with at least 1 minute between assessments;

          -  Have a body weight between 45 and 113 kg (99 and 250 lbs).

        Exclusion Criteria:

          -  Have known prolonged QT syndrome or QTcB interval of >0.500 sec as measured at
             screening on a 12 lead ECG; familial long QT syndrome; previous Torsades de Pointes;
             ventricular fibrillation; or sustained ventricular tachycardia (VT).

          -  Have a QRS >0.140 sec;

          -  Documented previous episodes of second or third-degree atrioventricular block;

          -  Have clinically significant persistent bradycardia with ventricular rate below 50
             beats/min, sick-sinus syndrome or pacemaker;

          -  Have clinically significant moderate or severe aortic valvular stenosis (gradient >25
             mmHg), hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or
             constrictive pericarditis;

          -  Have Class III or Class IV congestive heart failure at screening or admission, or have
             been hospitalized for heart failure in the previous 6 months;

          -  Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or
             acute coronary syndrome within 30 days prior to entry into the study; h) Have serious
             pulmonary, hepatic, metabolic, renal (serum creatinine > 2.0 mg/dl), gastrointestinal,
             central nervous system (CNS) or psychiatric disease, end-stage disease states, or any
             other disease that could interfere with the conduct or validity of the study or
             compromise subject safety;

          -  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;

          -  Potassium (K+) <3.5 mmol/L or >5.5 mmol/L or magnesium (Mg2+) below the lower limit of
             normal (Mg2+< 0.65 mmol/L in subjects 65 years or younger and <0.80 mmol/L in subjects
             66 years or older). (Both K+ and Mg2+ should be corrected prior to dosing);

          -  Have clinical evidence of digoxin toxicity;

          -  Have received an oral Class I or Class III antiarrhythmic agent (including sotalol)
             within 3 days of randomisation or oral amiodarone within 4 weeks, or have received
             intravenous Class I or Class III antiarrhythmic agent or i.v. amiodarone within 24
             hours prior to start of dosing;

          -  Have any other surgical or medical condition that, in the judgment of the clinical
             Investigator might warrant exclusion or be contraindicated for safety reasons;

          -  Be concurrently participating in another drug study or have received an
             investigational drug within 30 days prior to screening;

          -  Be unable to communicate well with the Investigator and to comply with the
             requirements of the entire study;