ArrhythmiaPhase 2NCT00137293
Study Evaluating GAP-486 in Heart Rhythm
A Phase 2 study testing GAP-486 (ZP-123) and 0.9% Sodium Chloride, USP in people with Arrhythmia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 7 sites in 2 countries.
Trial summary
The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- GAP-486 (ZP-123) and 0.9% Sodium Chloride, USP
- How many people
- 30 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2005to Oct 2006
- 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 undergoing an electrophysiology study for evaluation of heart rhythm.
Who cannot join
- Patients with uncontrolled blood pressure
- Patients with certain cardiac risk factors
- Patients with significant kidney or liver problems
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada4 sites
Study site
Montreal, Quebec, H1T 1CB
Study site
Montreal, Quebec, H2L 4M1
Study site
Ottawa, Ontario, K1Y 4W7
Study site
Toronto, Ontario, M5B 1W8
United States3 sites
Study site
Hershey, Pennsylvania, 17033
Study site
San Francisco, California, 94143
Study site
Washington D.C., District of Columbia, 20010
About this study
Official title: A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486
The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.
- Conditions
- Arrhythmia
- Being tested
- GAP-486 (ZP-123), 0.9% Sodium Chloride, USP
- Keywords
- Arrhythmia, syncope, antiarrhythmic
- Medical subject headings
- Arrhythmias, Cardiac, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAP-486 (ZP-123)Drug
0.9% Sodium Chloride, USPDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.
Secondary outcomes (1)
This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startNov 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137293
- Sponsor's protocol ID
- 3163K1-201
- Status last verified
- Dec 2007
- First submitted
- 25 Aug 2005
- Last updated
- 10 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486
- ClinicalTrials.gov ID
- NCT00137293
- Acronym / sponsor ID
- 3163K1-201
- Conditions
- Arrhythmia
- Keywords
- Arrhythmia, syncope, antiarrhythmic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 29 Aug 2005 (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 learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing an electrophysiology study for evaluation of heart rhythm.
Key exclusion criteria (3 listed)
- Patients with uncontrolled blood pressure
- Patients with certain cardiac risk factors
- Patients with significant kidney or liver problems
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 |
|---|---|---|
| GAP-486 (ZP-123) | Drug | – |
| 0.9% Sodium Chloride, USP | Drug | – |
Primary outcome
This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.
1 secondary outcome
This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article.
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 10 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
7 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 GAP-486 (ZP-123) and 0.9% Sodium Chloride, USP in people with Arrhythmia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 7 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 1 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: stopped early, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States. 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. 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?
This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.. 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 10 Dec 2007.