Atrial FibrillationPhase 3NCT00035477
Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
A Phase 3 study testing Azimilide Dihydrochloride in people with Atrial Fibrillation, run by Forest Laboratories at 82 sites in 2 countries.
Trial summary
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Azimilide Dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 82 sitesin 2 countries
- Study dates
- Sep 2000to Oct 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening
- Require the procedure of cardioversion (electric shock to correct heart rhythm)
- In the investigator's opinion, be likely to maintain sinus rhythm after cardioversion.
- Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines.
Who cannot join
- Previously unsuccessful electrical cardioversions
- Failed to respond to any Class III antiarrhythmic drugs
- Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
Trial locations and contacts
82 sites in 2 countries.
82 sites in 2 countries
United States69 sites
Heart Care Group PC
Allentown, Pennsylvania, 18106
Androscoggin Cardiology Associates Research
Auburn, Maine, 04201
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, 15009
Beloit Clinic, SC
Beloit, Wisconsin, 53511
Cardiovascular Associates of Penisula
Burlingame, California, 94010
Charleston Cardiology
Charleston, South Carolina, 29403
Lindner Clinical Trial Ctr.
Cincinnati, Ohio, 45219
University Hospitals of Cleveland
Cleveland, Ohio, 44106
UT Southwestern Medical Center
Dallas, Texas, 75390
Cardiology Consultants
Daytona Beach, Florida, 32114
VA Medical Center
Decatur, Georgia, 30033
Western Cardiology Assoc.
Denver, Colorado, 80218
Regional Heart Center
Duluth, Minnesota, 55805
Duke Medical Center
Durham, North Carolina, 27710
Elgin Cardiology Associates
Elgin, Illinois, 60120
Wisconsin Center for Clinical Research
Elkhorn, Wisconsin, 53121
San Diego Cardiovascular Research Associates
Encinitas, California, 92024
C/O Research Office Attn: Cardiovascular Research Dept.
Fort Lauderdale, Florida, 33316
Heart Center Medical Group
Fort Wayne, Indiana, 46804
Altru Health System Research Center
Grand Forks, North Dakota, 58201
Hartford Hospital
Hartford, Connecticut, 06102
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Hillsboro Cardiology
Hillsboro, Oregon, 97123
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Methodist Hospital
Houston, Texas, 77030
The Care Group
Indianapolis, Indiana, 46260
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Dean/Riverview Clinic
Janesville, Wisconsin, 53547
The Pavillion
Jenkintown, Pennsylvania, 19046
La Mesa Cardiac Center, a Medical Group
La Mesa, California, 91942
Richard Gilmore 501 S. Ryan Street
Lake Charles, Louisiana, 70601
Lakeland Regional Medical
Lakeland, Florida, 33805
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
Good Samaritan Hospital
Los Angeles, California, 90017
LAC + USC Medical Center
Los Angeles, California, 90033
Cardiology Section, West Los Angeles VA Hospital
Los Angeles, California, 90073
University of Louisville-Cardiology
Louisville, Kentucky, 40202
Louisville Cardiology Medical Group, P.S.C.
Louisville, Kentucky, 40207
University of Wisconsin Madison
Madison, Wisconsin, 53792
Stern Cardiovascular Center Research Department
Memphis, Tennessee, 38120
Merced Heart Associates
Merced, California, 95340
Khalid Hasan Sheikh 80 Fortenberry Road
Merritt Island, Florida, 32952
Wisconsin Center for Clinical Research
Milwaukee, Wisconsin, 53251
VA Medical Center Therapeutic Section
Minneapolis, Minnesota, 55417
The Heart Group, PC
Mobile, Alabama, 36608
Sutter Gould Medical Foundation
Modesto, California, 95335
Cardiovascular Instiute of the South
Morgan City, Louisiana, 70380
Tulane University
New Orleans, Louisiana, 70112
Riverside Regional Medical Center
Newport News, Virginia, 23601
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Florida Cardiology
Orlando, Florida, 32803
Cardiology Reasearch Assiocates
Ormond Beach, Florida, 32174
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Cardiovascular and Critical Care Associates, P.C.
Pittsburgh, Pennsylvania, 15224
Maine Medical Center
Portland, Maine, 04102
Oregon Health Sciences University
Portland, Oregon, 97201
ARI Clinical Trials
Redondo Beach, California, 90277
Inland Clinical Research
Riverside, California, 92501
Regional Cardiology Assoc.
Sacramento, California, 95819
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102
Heart and Vascular Inst. of Texas, PA
San Antonio, Texas, 78217
Cardiology Associates
San Diego, California, 92120
Daniel Gottlieb 16259 Sylvester Road SW Suite 401
Seattle, Washington, 98166
FHS Research
Tacoma, Washington, 98405
Riverside Osteopathic Hospital
Trenton, Michigan, 48183
University Medical Center
Tucson, Arizona, 85742
The George Washington University MFA
Washington D.C., District of Columbia, 20037
University of Massachusett
Worcester, Massachusetts, 01655
Cardiology Foundation of Lankenau
Wynnewood, Pennsylvania, 19096
Canada13 sites
University of Calgary
Calgary, Alberta, T2N 4N1
Rockyview General Hospital CV Lab Research
Calgary, Alberta, T2V 1P9
Neureka Research Corporation
Greater Sudbury, Ontario, P3E6B4
Hamilton Health Sciences Crop
Hamilton, Ontario, L8L 2X2
Cardiac Investigation Unit
London, Ontario, N6A 5A5
Montreal Heart Institute
Montreal, Quebec, H1T1C8
Recherche Cardiologie
Montreal, Quebec, H2L4M1
Hospital Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Quebec Heart Institute
Sainte-Foy, Quebec, G1V4G5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Cardiology Research St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Health Sciences Centre
Winnipeg, Manitoba, R3E0Z3
About this study
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms).
This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label follow-up phase to the study. This follow-up phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.
- Conditions
- Atrial Fibrillation
- Being tested
- Azimilide Dihydrochloride, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azimilide DihydrochlorideDrug
125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient
PlaceboDrug
placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo tablets in hospital and placebo tablets outpatient Receives: Drug: Placebo |
| 2 | Experimental | Azimilide tablets in hospital and azimilide tablets outpatient Receives: Drug: Azimilide Dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startSep 2000
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Preston M Dunnmon, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035477
- Sponsor's protocol ID
- 2000038
- Status last verified
- Sep 2011
- First submitted
- 3 May 2002
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00035477
- Acronym / sponsor ID
- 2000038
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 6 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms).
This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label follow-up phase to the study. This follow-up phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placeboplacebo tablets in hospital and placebo tablets outpatient |
| 2 | Experimental | Drug: Azimilide DihydrochlorideAzimilide tablets in hospital and azimilide tablets outpatient |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening
- Require the procedure of cardioversion (electric shock to correct heart rhythm)
- In the investigator's opinion, be likely to maintain sinus rhythm after cardioversion.
- Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines.
Key exclusion criteria (3 listed)
- Previously unsuccessful electrical cardioversions
- Failed to respond to any Class III antiarrhythmic drugs
- Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azimilide Dihydrochloride125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient | Drug | 2 |
| Placeboplacebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient | Drug | 1 |
Primary outcome
Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preston M Dunnmon, MD study director
Procter and Gamble
82 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azimilide Dihydrochloride in people with Atrial Fibrillation, run by Forest Laboratories at 82 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011.