Atrial FlutterPhase 2/3Scene 2NCT00476112
A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
A Phase 2/3 study testing Vernakalant Injection 20 mg/mL in people with Atrial Flutter, run by Advanz Pharma at 24 sites in 4 countries.
Trial summary
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- Vernakalant Injection 20 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 24 sitesin 4 countries
- Study dates
- Aug 2003to Sep 2004
- Phase
- Phase 2/3
- 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
- 18 years of age or older.
- Have an atrial arrhythmia with dysrhythmic symptoms that has been sustained for greater than 3 hours and up to 45 days.
- Have adequate anticoagulant therapy.
Who cannot join
- Have a QRS > 0.14 s unless patient has pacemaker or uncorrected QT > 0.440 seconds as measured on a 12-lead ECG.
- Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to enrollment, or have previously received RSD1235.
- Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
- Have received IV Class I or Class III antiarrhythmic drugs or IV amiodarone within 24 hours prior to dosing.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Denmark9 sites
Aalborg University
Aalborg
H:S Bispebjerg Hospital
Copenhagen
Centralsygehuset Esbjerg Varde
Esbjerg
Glostrup Amtssygehus
Glostrup Municipality
Gentofte Amtssygehus
Hellerup
Herlev Amtssygehus, Kardiologisk
Herlev
Sygehus Vendsyssel Hjorring
Hjørring
Holstebro centralsygehus
Holstebro
Hvidovre Hospital, Kardiologisk
Hvidovre
Canada8 sites
Heart Health Institute, Rockyview General Hospital
Calgary, Alberta, T2E 7C5
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences, Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1
CHUM-Hotel-Dieu de Montreal
Montreal, Quebec, H2W 1T8
Ottawa Hospitals (Civic & General)
Ottawa, Ontario, K1Y 4E9
United States5 sites
Thoracic and Cardiovascular Institute
Lansing, Michigan, 48910
Marshfield Clinic
Marshfield, Wisconsin, 54449
Medical College of Virginia
Richmond, Virginia, 23219
McGuire VA Medical Center
Richmond, Virginia, 23249
Regional Cardiology Associates
Sacramento, California, 95819
Sweden2 sites
Universitetssjukhuset MAS
Malmö
Centrallasarettet, Vasteras
Västerås
About this study
Official title: A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.
Read the detailed description
There are approximately 2 million reported prevalent cases of atrial fibrillation and atrial flutter (AFL) in the United States (Heart Disease \& Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. AF/AFL is usually associated with age, and general physical condition, rather than with a specific cardiac event, as is often the case with ventricular arrhythmia. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.
This Phase II/III trial is Cardiome's first study with RSD1235 for the treatment of atrial flutter. The study seeks to demonstrate RSD1235's abilities to convert AFL to sinus rhythm. The patient population will have atrial flutter of duration greater than 3 hours and less than or equal to 45 days.
This is a double-blind, placebo-controlled, randomized study in patients with AFL; stratification will be based on duration of AFL. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.
- Conditions
- Atrial Flutter
- Being tested
- Vernakalant Injection 20 mg/mL
- Keywords
- Atrial flutter, RSD1235
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vernakalant Injection 20 mg/mLDrug
Also called RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Atrial flutter duration of 3 hours to <45 days Receives: Drug: Vernakalant Injection 20 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the effectiveness of RSD1235 in the conversion of AFL to sinus rhythm. Treatment will be considered successful if there is treatment-induced conversion of AFL to sinus rhythm for a minimum of 1 minute duration by Hour 1.5.
Measured: The proportion of patients with atrial flutter who have treatment-induced conversion of atrial flutter to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.
Secondary outcomes (1)
To assess the safety of RSD1235 in this patient population and to assess the efficacy of RSD1235 in lowering the ventricular response rate in patients with AFL.
Measured: Treatment-induced reduction of the ventricular response rate within 50 minutes of first exposure to treatment for patient with atrial flutter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startAug 2003
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Investigators
- Sheila Grant, MBA, Study director, Advanz Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476112
- Sponsor's protocol ID
- 1235-0703B
- Acronym
- Scene 2
- Status last verified
- Mar 2008
- First submitted
- 18 May 2007
- Last updated
- 2 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Camm AJ, Toft E, Torp-Pedersen C, Vijayaraman P, Juul-Moller S, Ip J, Beatch GN, Dickinson G, Wyse DG; Scene 2 Investigators. Efficacy and safety of vernakalant in patients with atrial flutter: a randomized, double-blind, placebo-controlled trial. Europace. 2012 Jun;14(6):804-9. doi: 10.1093/europace/eur416. Epub 2012 Jan 29.
PubMed 22291438
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
- ClinicalTrials.gov ID
- NCT00476112
- Acronym / sponsor ID
- Scene 2 / 1235-0703B
- Conditions
- Atrial Flutter
- Keywords
- Atrial flutter, RSD1235
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Advanz PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Aug 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 21 May 2007 (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 will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.
Detailed description
There are approximately 2 million reported prevalent cases of atrial fibrillation and atrial flutter (AFL) in the United States (Heart Disease \& Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. AF/AFL is usually associated with age, and general physical condition, rather than with a specific cardiac event, as is often the case with ventricular arrhythmia. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.
This Phase II/III trial is Cardiome's first study with RSD1235 for the treatment of atrial flutter. The study seeks to demonstrate RSD1235's abilities to convert AFL to sinus rhythm. The patient population will have atrial flutter of duration greater than 3 hours and less than or equal to 45 days.
This is a double-blind, placebo-controlled, randomized study in patients with AFL; stratification will be based on duration of AFL. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vernakalant Injection 20 mg/mLAtrial flutter duration of 3 hours to <45 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older.
- Have an atrial arrhythmia with dysrhythmic symptoms that has been sustained for greater than 3 hours and up to 45 days.
- Have adequate anticoagulant therapy.
Key exclusion criteria (4 listed)
- Have a QRS > 0.14 s unless patient has pacemaker or uncorrected QT > 0.440 seconds as measured on a 12-lead ECG.
- Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to enrollment, or have previously received RSD1235.
- Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
- Have received IV Class I or Class III antiarrhythmic drugs or IV amiodarone within 24 hours prior to dosing.
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 |
|---|---|---|
| Vernakalant Injection 20 mg/mLAlso: RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv) | Drug | 1 |
Primary outcome
To demonstrate the effectiveness of RSD1235 in the conversion of AFL to sinus rhythm. Treatment will be considered successful if there is treatment-induced conversion of AFL to sinus rhythm for a minimum of 1 minute duration by Hour 1.5.
Time frame: The proportion of patients with atrial flutter who have treatment-induced conversion of atrial flutter to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.
1 secondary outcome
To assess the safety of RSD1235 in this patient population and to assess the efficacy of RSD1235 in lowering the ventricular response rate in patients with AFL.
Time frame: Treatment-induced reduction of the ventricular response rate within 50 minutes of first exposure to treatment for patient with atrial flutter.
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 2 Apr 2008.
- Derived from this study: PubMed 22291438Camm AJ, Toft E, Torp-Pedersen C, Vijayaraman P, Juul-Moller S, Ip J, Beatch GN, Dickinson G, Wyse DG; Scene 2 Investigators. Efficacy and safety of vernakalant in patients with atrial flutter: a randomized, double-blind, placebo-controlled trial. Europace. 2012 Jun;14(6):804-9. doi: 10.1093/europace/eur416. Epub 2012 Jan 29.
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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.
Sheila Grant, MBA study director
Advanz Pharma
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vernakalant Injection 20 mg/mL in people with Atrial Flutter, run by Advanz Pharma at 24 sites in 4 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 3 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 2 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 24 sites in Denmark, Canada, United States, Sweden. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 effectiveness of RSD1235 in the conversion of AFL to sinus rhythm. Treatment will be considered successful if there is treatment-induced conversion of AFL to sinus rhythm for a minimum of 1 minute duration by Hour 1.5. (time frame: The proportion of patients with atrial flutter who have treatment-induced conversion of atrial flutter to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.). 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 NCT00476112, which also lists 1 linked publication.
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 2 Apr 2008.