Left Ventricle FunctionPhase 2NCT00748982
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
A Phase 2 study testing AZD1305 in people with Left Ventricle Function, run by AstraZeneca at 1 site in Sweden.
Trial summary
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Left Ventricle Function
- What is being tested?
- AZD1305
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to Jul 2009
- 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
- Male patients and postmenopausal women
- Mildly/moderately decreased heart function
- Regular heart rhythm
Who cannot join
- Potassium outside normal reference values
- Child bearing potential
- Severely decreased heart function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Single-blind, Randomised, Placebo-controlled Phase IIa Study to Investigate the Effect of AZD1305 Given as an Intravenous (iv) Infusion on Left Ventricular Performance in Patients With Left Ventricular Dysfunction
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction
- Conditions
- Left Ventricle Function
- Being tested
- AZD1305, Placebo
- Keywords
- AZD1305, anti-arrhythmics, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1305Drug
iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
PlaceboDrug
iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD1305 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF), Change From Baseline
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
Measured: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
Secondary outcomes (3)
Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group
To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.
Measured: From randomisation to last study visit (mean infusion time 1.6 hours)
Area Under Curve (AUC) ( µmol*h/L) of AZD1305
To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction
Measured: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.
QTcF Interval
Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula
Measured: Up to 24 hours following start of IV dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionJul 2009
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.
- Other trials for Left Ventricle FunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Lund, MD, Study director, AstraZeneca R&D, Mölndal, SwedenMarianne Hartford, MD, Principal investigator, AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748982
- Sponsor's protocol ID
- D3190C00013
- Other IDs
- 2008-001254-41, 2008
- Status last verified
- Jun 2011
- First submitted
- 5 Sep 2008
- Last updated
- 27 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Single-blind, Randomised, Placebo-controlled Phase IIa Study to Investigate the Effect of AZD1305 Given as an Intravenous (iv) Infusion on Left Ventricular Performance in Patients With Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT00748982
- Acronym / sponsor ID
- D3190C00013
- Conditions
- Left Ventricle Function
- Keywords
- AZD1305, anti-arrhythmics, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 13 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1305 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients and postmenopausal women
- Mildly/moderately decreased heart function
- Regular heart rhythm
Key exclusion criteria (3 listed)
- Potassium outside normal reference values
- Child bearing potential
- Severely decreased heart function
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 |
|---|---|---|
| AZD1305iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes | Drug | 1 |
| Placeboiv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes | Drug | 2 |
Primary outcome
Left Ventricular Ejection Fraction (LVEF), Change From Baseline
Time frame: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
3 secondary outcomes
Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group
Time frame: From randomisation to last study visit (mean infusion time 1.6 hours)
Area Under Curve (AUC) ( µmol*h/L) of AZD1305
Time frame: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.
QTcF Interval
Time frame: Up to 24 hours following start of IV dosing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Heart Failure, Ventricular Function, Left
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.
Helen Lund, MD study director
AstraZeneca R&D, Mölndal, Sweden
Marianne Hartford, MD principal investigator
AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden
1 site in 1 country: 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 Left Ventricle Function, run by AstraZeneca at 1 site in Sweden.
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 3 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 13 Jun 2011). 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?
Left Ventricular Ejection Fraction (LVEF), Change From Baseline (time frame: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out). 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 27 Jun 2011.