Atrial FibrillationPhase 3ACT 4NCT00281554
Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation
A Phase 3 study testing RSD1235 in people with Atrial Fibrillation, run by Astellas Pharma Inc at 40 sites in 6 countries.
Trial summary
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation. 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?
- RSD1235
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 40 sitesin 6 countries
- Study dates
- Oct 2005to Jan 2007
- 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
- Subject must have symptomatic AF
- Subject must have adequate anticoagulant therapy
Who cannot join
- Subject may not have Class IV congestive heart failure.
- Subject may not have uncorrected electrolyte imbalance.
Trial locations and contacts
40 sites in 6 countries.
40 sites in 6 countries
United States10 sites
Study site
Atlanta, Georgia, 30322
Study site
Austin, Texas, 78756
Study site
Boston, Massachusetts, 02135
Study site
Chicago, Illinois, 60637
Study site
Huntsville, Alabama, 35801
Study site
Lansing, Michigan, 48910
Study site
Marshfield, Wisconsin, 54449
Study site
Oak Lawn, Illinois, 60453
Study site
Richmond, Virginia, 23249
Study site
San Antonio, Texas, 78229
Argentina9 sites
Study site
Buenos Aires, B8185SAN
Study site
Buenos Aires, C1064AAR
Study site
Buenos Aires, C1406GZL
Study site
Buenos Aires, CP1280
Study site
Buenos Aires, CP1437
Study site
Corrientes, CP3400
Study site
De Buenos Aires
Study site
Rosario
Study site
Tulunaw, CP4000
Denmark6 sites
Study site
Aalborg, DK-9000
Study site
Esbjerg, DK-9800
Study site
Hjørring, DK-9800
Study site
Hvidovre, DK-2650
Study site
København NV, DK-2400
Study site
Køge, 4600
South Africa6 sites
Study site
Berea Durban, 4001
Study site
Bloemfontein, 9301
Study site
Centurion, 0157
Study site
Parow, 7500
Study site
Somerset West, 7130
Study site
Westdene Bloemfontein, 9301
Canada5 sites
Study site
Calgary, Alberta, T2N 4N1
Study site
Montreal, Quebec, G2K 4N1
Study site
Montreal, Quebec, H2W 1T8
Study site
Ottawa, Ontario, K1Y 4E9
Study site
Terrebonne, Quebec, J6V 2H2
Sweden4 sites
Study site
Malmö, SE-205-02
Study site
Mölndal, SE-431-80
Study site
Örebro, SE-701-85
Study site
Stockholm, SE-182-88
About this study
Official title: A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- RSD1235
- Keywords
- Investigational Therapies, Atrial Fibrillation, Treatment Efficacy, Treatment Effectiveness, Safety, RSD1235
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSD1235Drug
Also called vernakalant, Kynapid
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RSD1235 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute
Measured: Infusion plus 1.5 hours
Secondary outcomes (1)
Evaluate safety
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanz Pharma
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281554
- Sponsor's protocol ID
- 05-7-012
- Acronym
- ACT 4
- Status last verified
- Apr 2008
- First submitted
- 24 Jan 2006
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Stiell IG, Dickinson G, Butterfield NN, Clement CM, Perry JJ, Vaillancourt C, Calder LA. Vernakalant hydrochloride: A novel atrial-selective agent for the cardioversion of recent-onset atrial fibrillation in the emergency department. Acad Emerg Med. 2010 Nov;17(11):1175-82. doi: 10.1111/j.1553-2712.2010.00915.x.
PubMed 21175515Stiell IG, Roos JS, Kavanagh KM, Dickinson G. A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm. Am Heart J. 2010 Jun;159(6):1095-101. doi: 10.1016/j.ahj.2010.02.035.
PubMed 20569725
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00281554
- Acronym / sponsor ID
- ACT 4 / 05-7-012
- Conditions
- Atrial Fibrillation
- Keywords
- Investigational Therapies, Atrial Fibrillation, Treatment Efficacy, Treatment Effectiveness, Safety, RSD1235
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Advanz Pharma
- Study start
- Oct 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 25 Jan 2006 (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.
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RSD1235 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must have symptomatic AF
- Subject must have adequate anticoagulant therapy
Key exclusion criteria (2 listed)
- Subject may not have Class IV congestive heart failure.
- Subject may not have uncorrected electrolyte imbalance.
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 |
|---|---|---|
| RSD1235Also: vernakalant, KynapidIV | Drug | 1 |
Primary outcome
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute
Time frame: Infusion plus 1.5 hours
1 secondary outcome
Evaluate safety
Time frame: End of study
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 Apr 2008.
- Derived from this study: PubMed 21175515Stiell IG, Dickinson G, Butterfield NN, Clement CM, Perry JJ, Vaillancourt C, Calder LA. Vernakalant hydrochloride: A novel atrial-selective agent for the cardioversion of recent-onset atrial fibrillation in the emergency department. Acad Emerg Med. 2010 Nov;17(11):1175-82. doi: 10.1111/j.1553-2712.2010.00915.x.
- Derived from this study: PubMed 20569725Stiell IG, Roos JS, Kavanagh KM, Dickinson G. A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm. Am Heart J. 2010 Jun;159(6):1095-101. doi: 10.1016/j.ahj.2010.02.035.
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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.
Use Central Contact study director
Astellas Pharma US, Inc.
40 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSD1235 in people with Atrial Fibrillation, run by Astellas Pharma Inc at 40 sites in 6 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 2 inclusion and 2 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 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Argentina, Denmark, South Africa, Canada and 1 more country. 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. 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?
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute (time frame: Infusion plus 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00281554, which also lists 2 linked publications.
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 Apr 2008.