Atrial FibrillationPhase 2NCT00267930
Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
A Phase 2 study testing Vernakalant (oral) in people with Atrial Fibrillation, run by Advanz Pharma at 22 sites in 4 countries.
Trial summary
This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vernakalant (oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Dec 2005to Aug 2006
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration
- Subjects must have adequate anticoagulant therapy
Who cannot join
- Subjects may not have Class III or Class IV congestive heart failure
- Subjects may not have uncorrected electrolyte imbalance
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Denmark9 sites
Aalborg Sygehus Syd
Aalborg, 9100
Aarhus Sygehus Kardiologisk Afd. A
Aarhus, 8000
Bispebjerg Hospital
Copenhagen
Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital
Frederiksberg, 2000
KAS Gentofte Kardiologisk Afdeling
Hellerup
KAS Herlev
Herlev, 2730
Sygehus Vendsyssel Hjorring
Hjørring, 9800
Roskilde Amts Sygehus Koge
Køge, 4600
Medicinsk Afdeling Kolding Sygehus
Kolding, 6000
Netherlands7 sites
Reinier de Graaf Gasthuis
Delft
Catharina Ziekenhuis
Eindhoven
Medisch Spectrum Twente
Enschede
University Medical Center Groningen (UMCG)
Groningen
Trial sectie Cardiologie
Heerlen
Academisch Ziekenhuis Maastricht
Maastricht
Stichting Sint Antonius Ziekenhuis
Nieuwegein
United States4 sites
Penn State Heart & Vascular Institute
Hershey, Pennsylvania, 17033
The Heart Center, P.C.
Huntsville, Alabama, 35801
Marshfield Clinic
Marshfield, Wisconsin, 54449
Cardiovascular Consultants Medical Group, Inc.
Walnut Creek, California, 94598
Canada2 sites
Foothills Hospital
Calgary, Alberta, T2N 2T9
Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu
Montreal, Quebec, H2W 1T8
About this study
Official title: A Pilot Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centred Safety, Tolerability and Preliminary Efficacy Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion Form AF
This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration
- Conditions
- Atrial Fibrillation
- Being tested
- Vernakalant (oral), Placebo comparator
- Keywords
- AFib, AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vernakalant (oral)Drug
Also called RSD1235-SR
Placebo comparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d Receives: Drug: Placebo comparator |
| 2 | Experimental | Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d Receives: Drug: Vernakalant (oral) |
| 3 | Experimental | Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d Receives: Drug: Vernakalant (oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All subjects who were exposed to the investigational medication were evaluated for safety.
Measured: Subjects were assessed for safety within Day 58 of dosing
Secondary outcomes (2)
Recurrence of AF/AFL or withdrawal
Measured: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing
Improvement in AF symptoms
Measured: Time to improvement in AF symptoms within Day 28 of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startDec 2005
- Study completionAug 2006
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Greg Beatch, PhD, Study director, Advanz Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267930
- Sponsor's protocol ID
- 1235-SR-1005
- Status last verified
- Dec 2008
- First submitted
- 20 Dec 2005
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centred Safety, Tolerability and Preliminary Efficacy Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion Form AF
- ClinicalTrials.gov ID
- NCT00267930
- Acronym / sponsor ID
- 1235-SR-1005
- Conditions
- Atrial Fibrillation
- Keywords
- AFib, AF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Advanz PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 22 Dec 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.
This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo comparatorTier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d |
| 2 | Experimental | Drug: Vernakalant (oral)Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d |
| 3 | Experimental | Drug: Vernakalant (oral)Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration
- Subjects must have adequate anticoagulant therapy
Key exclusion criteria (2 listed)
- Subjects may not have Class III or Class IV congestive heart failure
- Subjects 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 |
|---|---|---|
| Vernakalant (oral)Also: RSD1235-SR | Drug | 2, 3 |
| Placebo comparator | Drug | 1 |
Primary outcome
All subjects who were exposed to the investigational medication were evaluated for safety.
Time frame: Subjects were assessed for safety within Day 58 of dosing
2 secondary outcomes
Recurrence of AF/AFL or withdrawal
Time frame: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing
Improvement in AF symptoms
Time frame: Time to improvement in AF symptoms within Day 28 of dosing
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 18 Dec 2008.
- Related InfoLink provided by the sponsor.
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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.
Greg Beatch, PhD study director
Advanz Pharma
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vernakalant (oral) in people with Atrial Fibrillation, run by Advanz Pharma at 22 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 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 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Denmark, Netherlands, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
All subjects who were exposed to the investigational medication were evaluated for safety. (time frame: Subjects were assessed for safety within Day 58 of dosing). 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 18 Dec 2008.