Heart DiseasePhase 2NCT00907764
Stress Echocardiography Study With Regadenoson
A Phase 2 study testing regadenoson in people with Heart Disease and Coronary Artery Disease, run by Gilead Sciences at 1 site in United Kingdom.
Trial summary
Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging. This study will test whether regadenoson is an appropriate stress agent for stress echocardiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Coronary Artery Disease
- What is being tested?
- regadenoson
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Apr 2010
- 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
- Patients with a clinically indicated dobutamine echocardiogram showing normal wall motion at rest and abnormal wall motion with stress
- Patients with a clinically indicated dipyridamole echocardiogram showing normal perfusion and wall motion at rest and abnormal perfusion with or without abnormal wall motion with stress
Who cannot join
- Any condition precluding the safe administration of dobutamine, dipyridamole or SonoVue for echocardiography
- Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography
Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging. This study will test whether regadenoson is an appropriate stress agent for stress echocardiography.
- Conditions
- Heart Disease, Coronary Artery Disease
- Being tested
- regadenoson
- Medical subject headings
- Heart Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regadenosonDrug
400 ug, IV
| Study group | Role | What they receive |
|---|---|---|
| Regadenoson alone | Experimental | Not described Receives: Drug: regadenoson |
| Regadenoson with exercise | Experimental | Not described Receives: Drug: regadenoson |
| Regadenoson with contrast agent | Experimental | Not described Receives: Drug: regadenoson |
| Regadenoson with contrast agent (perfusion) | Experimental | Not described Receives: Drug: regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent.
Measured: Within 12 minutes after dosing
Secondary outcomes (1)
Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications.
Measured: Up to day 29 after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roxy Senior, Principal investigator, Northwick Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907764
- Sponsor's protocol ID
- CVT 5127
- Status last verified
- Jan 2014
- First submitted
- 20 May 2009
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography
- ClinicalTrials.gov ID
- NCT00907764
- Acronym / sponsor ID
- CVT 5127
- Conditions
- Heart Disease, Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 May 2009 (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.
Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging. This study will test whether regadenoson is an appropriate stress agent for stress echocardiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regadenoson alone | Experimental | Drug: regadenoson |
| Regadenoson with exercise | Experimental | Drug: regadenoson |
| Regadenoson with contrast agent | Experimental | Drug: regadenoson |
| Regadenoson with contrast agent (perfusion) | Experimental | Drug: regadenoson |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a clinically indicated dobutamine echocardiogram showing normal wall motion at rest and abnormal wall motion with stress
- Patients with a clinically indicated dipyridamole echocardiogram showing normal perfusion and wall motion at rest and abnormal perfusion with or without abnormal wall motion with stress
Key exclusion criteria (2 listed)
- Any condition precluding the safe administration of dobutamine, dipyridamole or SonoVue for echocardiography
- Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
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 |
|---|---|---|
| regadenoson400 ug, IV | Drug | Regadenoson alone, Regadenoson with contrast agent, Regadenoson with contrast agent (perfusion), Regadenoson with exercise |
Primary outcome
Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent.
Time frame: Within 12 minutes after dosing
1 secondary outcome
Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications.
Time frame: Up to day 29 after dosing
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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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.
Roxy Senior principal investigator
Northwick Park Hospital
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 regadenoson in people with Heart Disease and Coronary Artery Disease, run by Gilead Sciences at 1 site in United Kingdom.
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: stopped early, as of the sponsor's last update on 23 Jan 2014. 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 United Kingdom. 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 was stopped early (reason given: Slow enrollment). 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?
Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent. (time frame: Within 12 minutes after 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 23 Jan 2014.