Atrial FibrillationPhase 2TUNDRA-AFNCT01259622
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
A Phase 2 study testing saline and K201 in people with Atrial Fibrillation, run by Sequel Pharmaceuticals, Inc at 17 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety. 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?
- saline and K201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Feb 2011to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
- Atrial fibrillation documented by ECG at the start of study drug infusion.
Who cannot join
- Previous exposure to K201
- QTcF (Fridericia correction) >440 ms
- QRS interval > 140 ms
- Paced atrial or paced ventricular rhythm on ECG
- History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
- History of amiodarone (oral or IV) in the last 3 months.
Show all 12Show fewer
- Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
- History of failed electrical cardioversion at any time in the past
- History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
- History or family history of Long QT Syndrome
- History of ventricular tachycardia requiring drug or device therapy
- Ejection fraction of 40% or less.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Denmark14 sites
Study site
Copenhagen
Study site
Esbjerg
Study site
Glostrup Municipality
Study site
Haderslev
Study site
Hellerup
Study site
Herlev
Study site
Hvidovre
Study site
Kolding
Study site
Odense
Study site
Roskilde
Study site
Silkeborg
Study site
Svendborg
Study site
Varde
Study site
Viborg
About this study
Official title: A mulTi-center, Randomized, doUble-bliNded, Placebo-controlled Dose-escalating Study of the Effects of K201 on the RestorAtion of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation of Recent Onset
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
- Conditions
- Atrial Fibrillation
- Being tested
- saline, K201
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
intravenous infusion
K201Drug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: saline |
| K201 | Experimental | intravenous K201 Receives: Drug: K201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects who convert to sinus rhythm
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequel Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Chamberlin, MD, Study director, Sequel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259622
- Sponsor's protocol ID
- CJI-202
- Acronym
- TUNDRA-AF
- Status last verified
- May 2011
- First submitted
- 12 Dec 2010
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A mulTi-center, Randomized, doUble-bliNded, Placebo-controlled Dose-escalating Study of the Effects of K201 on the RestorAtion of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation of Recent Onset
- ClinicalTrials.gov ID
- NCT01259622
- Acronym / sponsor ID
- TUNDRA-AF / CJI-202
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sequel Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 14 Dec 2010 (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 evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
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 |
|---|---|---|
| placebo | Placebo comparator | Drug: saline |
| K201 | Experimental | Drug: K201intravenous K201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
- Atrial fibrillation documented by ECG at the start of study drug infusion.
Key exclusion criteria (12 listed)
- Previous exposure to K201
- QTcF (Fridericia correction) >440 ms
- QRS interval > 140 ms
- Paced atrial or paced ventricular rhythm on ECG
- History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of 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 |
|---|---|---|
| salineintravenous infusion | Drug | placebo |
| K201intravenous infusion | Drug | K201 |
Primary outcome
proportion of subjects who convert to sinus rhythm
Time frame: 24 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
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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.
Paul Chamberlin, MD study director
Sequel Pharmaceuticals
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing saline and K201 in people with Atrial Fibrillation, run by Sequel Pharmaceuticals, Inc at 17 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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Denmark, Israel. 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 was stopped early. Results are not available in the source record.
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?
proportion of subjects who convert to sinus rhythm (time frame: 24 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 16 May 2011.