Atrial FibrillationPhase 2RESTORATIONNCT00626652
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
A Phase 2 study testing K201 Injection in people with Atrial Fibrillation, run by Sequel Pharmaceuticals, Inc at 9 sites in 2 countries.
Trial summary
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, 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?
- K201 Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Mar 2008to Dec 2009
- 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
- Atrial fibrillation documented by ECG
- Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.
Who cannot join
- Systolic blood pressure <100 mmHg
- Heart rate <50 bpm
- Temperature >38°C
- QT or QTcB >440 ms
- QRS >140 ms
- Paced atrial or ventricular rhythm on ECG
Show all 18Show fewer
- Serum potassium <3.5 meq/L
- History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
- History of amiodarone in last 6 months.
- Clinical evidence of acute coronary syndrome
- Acute pulmonary edema or embolism
- Hyperthyroidism
- Acute pericarditis
- History of failed electrical cardioversion at any time
- History of torsades des pointes
- History of familial long QT interval syndrome
- History of ventricular tachycardia requiring drug or device therapy
- History of NYHA Heart Failure Class 3 or 4.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Israel7 sites
Study site
Ashkelon
Study site
Beersheba
Study site
Haifa
Study site
Holon
Study site
Jerusalem
Study site
Nazareth
Study site
Safed
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
- Conditions
- Atrial Fibrillation
- Being tested
- K201 Injection
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K201 InjectionDrug
single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: K201 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of sinus rhythm
Measured: 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequel Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sergey Pavlovich Golitsyn, Prof., Principal investigator, Russian Cardiologic Scientific and Manufacturing Complex of Roszdrav, Institute of Cardiology n.a. A.L.Myasnikov, Department of clinical electrophysiologyAmos Katz, Prof., Principal investigator, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626652
- Sponsor's protocol ID
- CJI-201
- Acronym
- RESTORATION
- Status last verified
- Jan 2010
- First submitted
- 18 Feb 2008
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00626652
- Acronym / sponsor ID
- RESTORATION / CJI-201
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Sequel Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Feb 2008 (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.
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: K201 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic atrial fibrillation
- Atrial fibrillation documented by ECG
- Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.
Key exclusion criteria (18 listed)
- Systolic blood pressure <100 mmHg
- Heart rate <50 bpm
- Temperature >38°C
- QT or QTcB >440 ms
- QRS >140 ms
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 |
|---|---|---|
| K201 Injectionsingle intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule | Drug | 1 |
Primary outcome
Restoration of sinus rhythm
Time frame: 24hrs
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 8 Jan 2010.
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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.
Sergey Pavlovich Golitsyn, Prof. principal investigator
Russian Cardiologic Scientific and Manufacturing Complex of Roszdrav, Institute of Cardiology n.a. A.L.Myasnikov, Department of clinical electrophysiology
Amos Katz, Prof. principal investigator
Barzilai Medical Center
9 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 K201 Injection in people with Atrial Fibrillation, run by Sequel Pharmaceuticals, Inc at 9 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 3 inclusion and 18 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 8 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Israel, Russia. 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 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?
Restoration of sinus rhythm (time frame: 24hrs). 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 8 Jan 2010.