Atrial FlutterPhase 3NCT00115791
Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
A Phase 3 study testing RSD1235 in people with Atrial Flutter and Atrial Fibrillation, run by Astellas Pharma Inc at 54 sites in 7 countries.
Trial summary
The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter, Atrial Fibrillation
- What is being tested?
- RSD1235
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 54 sitesin 7 countries
- Study dates
- Jun 2004to Jun 2005
- 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
- Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days
Who cannot join
- Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization
Trial locations and contacts
54 sites in 7 countries.
54 sites in 7 countries
United States19 sites
Investigative Site
Amarillo, Texas, 79106
Investigative Site
Baltimore, Maryland, 21201
Investigative Site
Birmingham, Alabama, 35213
Investigative Site
Cincinnati, Ohio, 45267
Investigative Site
Gainesville, Florida, 32610
Investigative Site
Holmdel, New Jersey, 07733
Investigative Site
Houston, Texas, 77030
Investigative Site
Huntsville, Alabama, 35801
Investigative Site
Indianapolis, Indiana, 46202
Investigative Site
Lansing, Michigan, 48910
Investigative Site
Marshfield, Wisconsin, 544449
Investigative Site
Orlando, Florida, 32803
Investigative Site
Petoskey, Michigan, 49770
Investigative Site
Port Charlotte, Florida, 33952
Investigative Site
Richmond, Virginia, 23249
Investigative Site
Saint Paul, Minnesota, 55102
Investigative Site
Shreveport, Louisiana, 71103
Investigative Site
Tacoma, Washington, 98405
Investigative Site
Tupelo, Mississippi, 38801
Denmark13 sites
Investigative Site
Aalborg
Investigative Site
Arhus C
Investigative Site
Esbjerg
Investigative Site
Fredericia
Investigative Site
Frederikssund
Investigative Site
Herlev
Investigative Site
Hjørring
Investigative Site
Holstebro
Investigative Site
Horsens
Investigative Site
Hvidovre
Investigative Site
København NV
Investigative Site
København S
Investigative Site
Køge
Canada10 sites
Investigative Site
Calgary, Alberta, T2N 2T9
Investigative Site
Edmonton, Alberta, T6G 2B7
Investigative Site
Halifax, Nova Scotia, B3H 1V7
Investigative Site
Montreal, Quebec, H1T 1C8
Investigative Site
Montreal, Quebec, H2L 4M1
Investigative Site
Montreal, Quebec, H2W 1T8
Investigative Site
Ottawa, Ontario, K1Y 4E9
Investigative Site
Ottawa, Ontario, K1Y K1Y
Investigative Site
Terrebonne, Quebec, J6V 2H2
Investigative Site
Toronto, Ontario, M5B 1W8
Argentina5 sites
Investigative Site
Buenos Aires, B8185XAN
Investigative Site
Buenos Aires, C1039AAO
Investigative Site
Buenos Aires, C1064AAR
Investigative Site
Buenos Aires, C1221ADC
Investigative Site
Mendoza, 5500
Sweden5 sites
Investigative Site
Malmö
Investigative Site
Mölndal
Investigative Site
Örebro
Investigative Site
Stockholm
Investigative Site
Uppsala
About this study
Official title: A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.
- Conditions
- Atrial Flutter, Atrial Fibrillation
- Being tested
- RSD1235, placebo
- Keywords
- Atrial Flutters, Atrial Fibrillations, RSD1235
- Medical subject headings
- Atrial Flutter, 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
placeboDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RSD1235 |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm
Measured: Infusion plus 1.5 hours
Secondary outcomes (1)
To assess the time taken from exposure to first treatment to first conversion to sinus rhythm
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 posted27 Jun 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 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
- NCT00115791
- Sponsor's protocol ID
- 04-7-010
- Other IDs
- Cardiome 1235-0504
- Status last verified
- Mar 2008
- First submitted
- 26 Jun 2005
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
- ClinicalTrials.gov ID
- NCT00115791
- Acronym / sponsor ID
- 04-7-010
- Conditions
- Atrial Flutter, Atrial Fibrillation
- Keywords
- Atrial Flutters, Atrial Fibrillations, RSD1235
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Advanz Pharma
- Study start
- Jun 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 27 Jun 2005 (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.
The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RSD1235 |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days
Key exclusion criteria (1 listed)
- Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days 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 |
|---|---|---|
| RSD1235Also: vernakalant, KynapidIV | Drug | 1 |
| placeboIV | Drug | 2 |
Primary outcome
To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm
Time frame: Infusion plus 1.5 hours
1 secondary outcome
To assess the time taken from exposure to first treatment to first conversion to sinus rhythm
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 1 Apr 2008.
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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.
54 sites in 7 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 Flutter and Atrial Fibrillation, run by Astellas Pharma Inc at 54 sites in 7 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 1 inclusion and 1 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 1 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 54 sites in United States, Denmark, Canada, Argentina, Sweden and 2 more countries. 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 demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm (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?
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 1 Apr 2008.