Atrial FibrillationPhase 2NCT00643448
Explorative Study of AZD1305 in Atrial Fibrillation Patients
A Phase 2 study testing AZD1305 in people with Atrial Fibrillation, run by AstraZeneca at 18 sites in 6 countries.
Trial summary
Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- AZD1305
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 18 sitesin 6 countries
- Study dates
- Mar 2008to Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
- Sinus rhythm at randomisation
Who cannot join
- Haemodynamically unstable condition as judged by the Investigator, systolic BP <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation
- Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
- Sinus bradycardia (<50 beats per minute (bpm)) at randomisation
- QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
- Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
- QRS duration >120 ms at randomisation
- Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John's Worth
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Denmark6 sites
Research Site
Aalborg
Research Site
Copenhagen
Research Site
Esbjerg
Research Site
Hvidovre
Research Site
Silkeborg
Research Site
Svendborg
Slovakia4 sites
Research Site
Košice
Research Site
Nitra
Research Site
Nové Zámky
Research Site
Rimavská Sobota
About this study
Official title: A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship Between QTcF Interval at First Dose (Loading Dose) and at Steady State After Treatment With AZD1305 Extended-release Tablets or Placebo When Given to Patients With Documented AF
Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state
- Conditions
- Atrial Fibrillation
- Being tested
- AZD1305, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1305Drug
AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
AZD1305Drug
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
PlaceboDrug
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
| Study group | Role | What they receive |
|---|---|---|
| AZD1305 loading dose 250 mg + 125 mg | Experimental | Tablets Receives: Drug: AZD1305 |
| AZD1305 loading dose 500 mg + placebo | Experimental | Tablets Receives: Drug: AZD1305 |
| Placebo corresponding to AZD1305 loading dose | Placebo comparator | Tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum QTcF
Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.
Measured: During treatment days 2-10
Secondary outcomes (3)
Adverse Events (AE)
Number of patients who had at least one AE according to the definition in the study protocol
Measured: During treatment days 2-10
Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state
Population PK model parameter estimates derived from plasma concentrations of AZD1305
Measured: During treatment days 1-10
Compliance With Trans Telephonic Monitoring (TTM)
Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis
Measured: During treatment days 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Egstrup, Principal investigator, Svendborg Sygehus, Forsknings-og udviklingsafd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643448
- Sponsor's protocol ID
- D3190C00019
- Other IDs
- 2007-007058-79
- Status last verified
- Dec 2011
- First submitted
- 20 Mar 2008
- Last updated
- 26 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Egstrup K, Bergfeldt L, Duris T, Gullestad L, Kochmanski M, Kusnierz B, Nielsen T, Sawicki S, Aunes-Jansson M, Edvardsson N, Frison L, Johansson S, Berggren A. QT response after a test dose and during maintenance therapy with AZD1305 in patients with atrial fibrillation: a double-blind, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2011 Jun 1;11(3):199-208. doi: 10.2165/11591750-000000000-00000.
PubMed 21619383
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship Between QTcF Interval at First Dose (Loading Dose) and at Steady State After Treatment With AZD1305 Extended-release Tablets or Placebo When Given to Patients With Documented AF
- ClinicalTrials.gov ID
- NCT00643448
- Acronym / sponsor ID
- D3190C00019
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Posted 26 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZD1305 loading dose 250 mg + 125 mg | Experimental | Drug: AZD1305Tablets |
| AZD1305 loading dose 500 mg + placebo | Experimental | Drug: AZD1305Tablets |
| Placebo corresponding to AZD1305 loading dose | Placebo comparator | Drug: PlaceboTablets |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
- Sinus rhythm at randomisation
Key exclusion criteria (7 listed)
- Haemodynamically unstable condition as judged by the Investigator, systolic BP <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation
- Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
- Sinus bradycardia (<50 beats per minute (bpm)) at randomisation
- QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
- Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
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 |
|---|---|---|
| AZD1305AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 | Drug | AZD1305 loading dose 250 mg + 125 mg |
| AZD1305AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 | Drug | AZD1305 loading dose 500 mg + placebo |
| PlaceboPlacebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2 | Drug | Placebo corresponding to AZD1305 loading dose |
Primary outcome
Maximum QTcF
Time frame: During treatment days 2-10
Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.
3 secondary outcomes
Adverse Events (AE)
Time frame: During treatment days 2-10
Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state
Time frame: During treatment days 1-10
Compliance With Trans Telephonic Monitoring (TTM)
Time frame: During treatment days 1-10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21619383Egstrup K, Bergfeldt L, Duris T, Gullestad L, Kochmanski M, Kusnierz B, Nielsen T, Sawicki S, Aunes-Jansson M, Edvardsson N, Frison L, Johansson S, Berggren A. QT response after a test dose and during maintenance therapy with AZD1305 in patients with atrial fibrillation: a double-blind, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2011 Jun 1;11(3):199-208. doi: 10.2165/11591750-000000000-00000.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Kenneth Egstrup principal investigator
Svendborg Sygehus, Forsknings-og udviklingsafd.
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1305 in people with Atrial Fibrillation, run by AstraZeneca at 18 sites in 6 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 7 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 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Denmark, Slovakia, Norway, Poland, Russia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum QTcF (time frame: During treatment days 2-10). 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 NCT00643448, 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 26 Jan 2012.