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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00526136




Registration number
NCT00526136
Ethics application status
Date submitted
5/09/2007
Date registered
10/09/2007
Date last updated
18/12/2008

Titles & IDs
Public title
Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study
Scientific title
Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study
Secondary ID [1] 0 0
1235-SR-202-AF
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Vernakalant (oral)

Placebo Comparator: 1 - Placebo (b.i.d.)

Experimental: 2 - Vernakalant (oral), 150 mg (b.i.d.)

Experimental: 3 - Vernakalant (oral), 300 mg (b.i.d.)

Experimental: 4 - Vernakalant (oral), 500 mg (b.i.d.)


Treatment: Drugs: Placebo


Treatment: Drugs: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first documented recurrence of symptomatic sustained AF.
Timepoint [1] 0 0
Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing
Primary outcome [2] 0 0
Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events
Timepoint [2] 0 0
Safety assessments within Day 120 of dosing
Secondary outcome [1] 0 0
Time to first documented recurrence of symptomatic or asymptomatic sustained AF
Timepoint [1] 0 0
Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing
Secondary outcome [2] 0 0
Time to first documented recurrence of symptomatic AF
Timepoint [2] 0 0
Time to first documented recurrence of symptomatic AF within 90 days of dosing
Secondary outcome [3] 0 0
Time to first documented recurrence of symptomatic or asymptomatic AF
Timepoint [3] 0 0
Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing
Secondary outcome [4] 0 0
Proportion of subjects in sinus rhythm on Day 90.
Timepoint [4] 0 0
Proportion of subjects in sinus rhythm on Day 90 of dosing
Secondary outcome [5] 0 0
Improvement in AF symptoms as assessed by an AF symptom checklist.
Timepoint [5] 0 0
Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing
Secondary outcome [6] 0 0
Improvement in QOL as measured by SF-36
Timepoint [6] 0 0
Improvement in QOL as measured by SF-36 within Day 90 of dosing

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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;

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [3] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
- Launceston
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment outside Australia
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Belgium
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Antwerp
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Bonheiden
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Leuven
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Roeselare
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Haskovo
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Pleven
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Rousse
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Sofia
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Zadar
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Plzen
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Praha
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Pribram
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Semily
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Germany
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Lviv
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Odessa
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Ukraine
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Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cardiome Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg,
300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained
symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).
Trial website
https://clinicaltrials.gov/show/NCT00526136
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Beatch, PhD
Address 0 0
Cardiome Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications