Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

This study has been completed.
Sponsor:
Information provided by:
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT00526136
First received: September 5, 2007
Last updated: December 17, 2008
Last verified: December 2008
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Drug: Placebo
Drug: Vernakalant (oral)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

Resource links provided by NLM:


Further study details as provided by Cardiome Pharma:

Primary Outcome Measures:
  • Time to first documented recurrence of symptomatic sustained AF. [ Time Frame: Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing ] [ Designated as safety issue: No ]
  • Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events [ Time Frame: Safety assessments within Day 120 of dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to first documented recurrence of symptomatic or asymptomatic sustained AF [ Time Frame: Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing ] [ Designated as safety issue: No ]
  • Time to first documented recurrence of symptomatic AF [ Time Frame: Time to first documented recurrence of symptomatic AF within 90 days of dosing ] [ Designated as safety issue: No ]
  • Time to first documented recurrence of symptomatic or asymptomatic AF [ Time Frame: Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing ] [ Designated as safety issue: No ]
  • Proportion of subjects in sinus rhythm on Day 90. [ Time Frame: Proportion of subjects in sinus rhythm on Day 90 of dosing ] [ Designated as safety issue: No ]
  • Improvement in AF symptoms as assessed by an AF symptom checklist. [ Time Frame: Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing ] [ Designated as safety issue: No ]
  • Improvement in QOL as measured by SF-36 [ Time Frame: Improvement in QOL as measured by SF-36 within Day 90 of dosing ] [ Designated as safety issue: No ]

Enrollment: 735
Study Start Date: March 2007
Study Completion Date: July 2008
Arms Assigned Interventions
Placebo Comparator: 1
Placebo (b.i.d.)
Drug: Placebo
Experimental: 2
Vernakalant (oral), 150 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Name: RSD1235-SR
Experimental: 3
Vernakalant (oral), 300 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Name: RSD1235-SR
Experimental: 4
Vernakalant (oral), 500 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Name: RSD1235-SR

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00526136

  Show 152 Study Locations
Sponsors and Collaborators
Cardiome Pharma
Investigators
Study Director: Gregory Beatch, PhD Cardiome Pharma
  More Information

Additional Information:
No publications provided by Cardiome Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp.
ClinicalTrials.gov Identifier: NCT00526136     History of Changes
Other Study ID Numbers: 1235-SR-202-AF
Study First Received: September 5, 2007
Last Updated: December 17, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
New Zealand: Medsafe
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: Ministry of Public Health
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Swissmedic
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Cardiome Pharma:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on September 22, 2014