Atrial FibrillationPhase 3NCT00035464
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
A Phase 3 study testing Azimilide Dihydrochloride in people with Atrial Fibrillation, run by Forest Laboratories at 103 sites in 2 countries.
Trial summary
Atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 431 participants
- Where
- 103 sitesin 2 countries
- Study dates
- Dec 2000to Jan 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities
- History of congestive heart failure and/or ischemic heart disease
- Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study
- At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm.
- Sinus rhythm immediately prior to dosing
Who cannot join
- Previously unsuccessful cardioversions within 60 days of screening period
- 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
- Previously in an azimilide study
Trial locations and contacts
103 sites in 2 countries.
103 sites in 2 countries
United States88 sites
Heart Care Group PC
Allentown, Pennsylvania, 18106-0880
Aurora Denver Cardiology
Aurora, Colorado, 80012
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, 15009
Beloit Clinic, SC
Beloit, Wisconsin, 53511
Cardiovascular Assoc. PC
Birmingham, Alabama, 35213
Boston Medical Center
Boston, Massachusetts, 02118
Cardiovascular Associates of Penisula
Burlingame, California, 94010
Capitol Interventional Cardiology
Carmichael, California, 95608
Charleston Cardiology
Charleston, South Carolina, 29403
MedSource, Inc
Chesapeake, Virginia, 23321
Mount Sinal Hospital Medical Center
Chicago, Illinois, 60608
Lindner Clinical Trial Ctr.
Cincinnati, Ohio, 45219
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5038
MidWest Cardiology Research Foundation
Columbus, Ohio, 43214
UT Southwestern Medical Center
Dallas, Texas, 75390-9047
Cardiology Consultants
Daytona Beach, Florida, 32114
VA Medical Center
Decatur, Georgia, 30033
Western Cardiology Assoc.
Denver, Colorado, 80218
Regional Heart Center
Duluth, Minnesota, 55802
Duke Medical Center
Durham, North Carolina, 27710
Elgin Cardiology Associates
Elgin, Illinois, 60120
C/O Research Office Attn: Cardiovascular Research Dept.
Fort Lauderdale, Florida, 33316
SW Florida Heart Group/Health Park Medical Center
Fort Myers, Florida, 33919
Heart Center Medical Group
Fort Wayne, Indiana, 46804
VA Central California Health Care System
Fresno, California, 93703
Valley Research
Fresno, California, 93720
Altru Health System Research Center
Grand Forks, North Dakota, 58201
Internal Medical Associates
Grand Island, Nebraska, 68803
Grass Valley Cardiology
Grass Valley, California, 95945
Hartford Hospital
Hartford, Connecticut, 06102
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Fairview Range Regional Health Services
Hibbing, Minnesota, 55746
Hillsboro Cardiology
Hillsboro, Oregon, 97123
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Methodist Hospital
Houston, Texas, 77030
The Care Group
Indianapolis, Indiana, 46260-1919
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Dean/Riverview Clinic
Janesville, Wisconsin, 53547-0551
The Pavillion
Jenkintown, Pennsylvania, 19046
San Diego Cardiovascular Associates
La Jolla, California, 92037
Richard Gilmore, MD 501 S Ryan Street
Lake Charles, Louisiana, 70601
Watson Clinic, LLP
Lakeland, Florida, 33805
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
University of Arkansas Medical Center
Little Rock, Arkansas, 72205
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
Marshfield Clinic
Marshfield, Wisconsin, 54449
Stern Cardiovascular Center Research Department
Memphis, Tennessee, 38120
Merced Heart Associates
Merced, California, 95340
Khalid Hassan Sheikh 80 Fontenberry Road
Merritt Island, Florida, 32952
VA Medical Center Therapeutic Section
Minneapolis, Minnesota, 55417
St. Patrick Hosp/Western Mt. Clinic Cardiology
Missoula, Montana, 59802
The Heart Group, PC
Mobile, Alabama, 36608
Sutter Gould Medical Foundation
Modesto, California, 95355
Cardiovascular of the South
Morgan City, Louisiana, 70380
Cardiovascular Institute of the South
New Iberia, Louisiana, 70560
Tulane University
New Orleans, Louisiana, 70112
Riverside Regional Medical Center
Newport News, Virginia, 23601
Illinois Heart & Lung Research Center, SC
Normal, Illinois, 61761-3587
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73104
Florida Cardiology
Orlando, Florida, 32803
Cardiology Research Assiocates
Ormond Beach, Florida, 32174
The Center for Advanced Cardiology
Park Ridge, Illinois, 60068
Nisus Research
Petoskey, Michigan, 49770
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
William Olney, MD 21 Whitehall Rd, Suite 200
Rochester, New Hampshire, 03867
Regional Cardiology Assoc.
Sacramento, California, 95819
Sacramento Heart and Vascular Medical Associates
Sacramento, California, 95825
Heart and Vascular Inst. of Texas, PA
San Antonio, Texas, 78217
Cardiology Associates
San Diego, California, 92120
Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
Seattle, Washington, 95165
Medical Research Institute
Slidell, Louisiana, 70458
Cardiovascular Institute of the South
Thibodaux, Louisiana, 70301
Riverside Osteopathic Hospital
Trenton, Michigan, 48183
Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
Tucson, Arizona, 85723
University Medical Center
Tucson, Arizona, 85742
The George Washington University MFA
Washington D.C., District of Columbia, 20037
Professional Research Network of Kansas
Wichita, Kansas, 67203
Cardiology & Int. Medicine
Williamsville, New York, 14221
University of Massachusett
Worcester, Massachusetts, 01655
Canada15 sites
Heart Health Institute
Calgary, Alberta, T2E7C5
Heart Health Research Center
Calgary, Alberta, T2E7C5
University of Calgary
Calgary, Alberta, T2N4N1
Neureka Research Corporation
Greater Sudbury, Ontario, P3E6B4
Hamilton Health Science Corp.
Hamilton, Ontario, L8L2X2
Cardiac Investigation Unit
London, Ontario, N6A5A5
Montreal Heart Institute
Montreal, Quebec, H1T1C8
Recharche Cardiologie
Montreal, Quebec, H2L4M1
Chum Hotel Dieu
Montreal, Quebec, H2WIT8
Hospital Sacre-Soeur de Montreal
Montreal, Quebec, H4J1C5
Niagara Health System Greater Niagara General Hospital
Niagara Falls, Ontario, L2E7H1
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7
Quebec Heart Institute
Sainte-Foy, Quebec, G1V4G5
St. Michael's Hospital
Toronto, Ontario, M5B1W6
Cardiology Research St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
About this study
Official title: Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients
Atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of 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 prolonging the time to the first symptomatic arrhythmia recurrence in patients with a history of atrial fibrillation and congestive heart failure and/or ischemic heart disease) and those without these conditions. 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. The follow-up phase of the study is designed 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, twice a day for 6 months
PlaceboDrug
placebo tablets, twice a day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo tablets Receives: Drug: Placebo |
| 2 | Experimental | 125 mg azimilide tablets Receives: Drug: Azimilide Dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
To prolong the tachycardia-free period in patients
Measured: 6 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 startDec 2000
- Primary completionJan 2004
- Study completionJan 2004
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
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Phillips, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035464
- Sponsor's protocol ID
- 2000037
- 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 in the Prophylactic Treatment of Patients
- ClinicalTrials.gov ID
- NCT00035464
- Acronym / sponsor ID
- 2000037
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (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 (an abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of 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 prolonging the time to the first symptomatic arrhythmia recurrence in patients with a history of atrial fibrillation and congestive heart failure and/or ischemic heart disease) and those without these conditions. 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. The follow-up phase of the study is designed 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 |
| 2 | Experimental | Drug: Azimilide Dihydrochloride125 mg azimilide tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities
- History of congestive heart failure and/or ischemic heart disease
- Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study
- At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm.
- Sinus rhythm immediately prior to dosing
Key exclusion criteria (4 listed)
- Previously unsuccessful cardioversions within 60 days of screening period
- 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
- Previously in an azimilide study
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, twice a day for 6 months | Drug | 2 |
| Placeboplacebo tablets, twice a day for 6 months | Drug | 1 |
Primary outcome
To prolong the tachycardia-free period in patients
Time frame: 6 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
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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.
Martin Phillips, MD study director
Procter and Gamble
103 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 103 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 5 inclusion and 4 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 103 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?
To prolong the tachycardia-free period in patients (time frame: 6 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.