StrokePhase 2NCT00073476
A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke
A Phase 2 study testing traxiprodil (CP-101,606) in people with Stroke, run by Pfizer at 29 sites in 8 countries.
Trial summary
The purpose of this study is to determine whether a new research medication is effective and safe for the treatment of acute stroke when given within 6 hours of the onset of stroke. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- traxiprodil (CP-101,606)
- How many people
- 300 participants
- Where
- 29 sitesin 8 countries
- Study dates
- Sep 2003to Feb 2005
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males \& females age 40-90 years
- Enrolled in study within 6 hours of onset of stroke symptoms
- Willing to sign informed consent form
- No significant disabilities prior to stroke
Who cannot join
- Treatment with t-PA (tissue plasminogen activator)
- Premorbid modified rankin scale score of 2 or more
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
United States12 sites
Pfizer Investigational Site
Allentown, Pennsylvania, 18103
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Dayton, Ohio, 45406
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
Dayton, Ohio, 45409
Pfizer Investigational Site
Dayton, Ohio, 45415
Pfizer Investigational Site
Fort Wayne, Indiana, 46804
Pfizer Investigational Site
Fort Wayne, Indiana, 46805
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19141
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Germany4 sites
Pfizer Investigational Site
Bad Neustadt an der Saale, 97616
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Lübeck, 23538
Spain4 sites
Pfizer Investigational Site
Madrid, 28007
Pfizer Investigational Site
Madrid, 28034
Pfizer Investigational Site
Santiago de Compostela, Galicia, 15706
Pfizer Investigational Site
Zaragoza, 50009
Hungary2 sites
Pfizer Investigational Site
Budapest, H-1021
Pfizer Investigational Site
Győr, H-9023
Italy2 sites
Pfizer Investigational Site
Pavia, 27100
Pfizer Investigational Site
Perugia, 06126
Portugal2 sites
Pfizer Investigational Site
Coimbra, Codex 3049
Pfizer Investigational Site
Lisbon, 1600
Singapore2 sites
Pfizer Investigational Site
Singapore, 169608
Pfizer Investigational Site
Singapore, 308433
About this study
Official title: A Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a 72-Hour Infusion of CP-101,606 in Subjects With Acute Ischemic Stroke.
The purpose of this study is to determine whether a new research medication is effective and safe for the treatment of acute stroke when given within 6 hours of the onset of stroke.
- Conditions
- Stroke
- Being tested
- traxiprodil (CP-101,606)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traxiprodil (CP-101,606)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
No or minimal neurological deficit at last visit
Marked neurological improvement at last visit
Secondary outcomes (3)
Modified Rankin scale at last visit
Mortality
Safety assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2003 (estimated)
- Study startSep 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073476
- Sponsor's protocol ID
- A1611005
- Status last verified
- Jun 2006
- First submitted
- 21 Nov 2003
- Last updated
- 22 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a 72-Hour Infusion of CP-101,606 in Subjects With Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT00073476
- Acronym / sponsor ID
- A1611005
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Feb 2005
- First posted
- 24 Nov 2003 (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 determine whether a new research medication is effective and safe for the treatment of acute stroke when given within 6 hours of the onset of stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males \& females age 40-90 years
- Enrolled in study within 6 hours of onset of stroke symptoms
- Willing to sign informed consent form
- No significant disabilities prior to stroke
Key exclusion criteria (2 listed)
- Treatment with t-PA (tissue plasminogen activator)
- Premorbid modified rankin scale score of 2 or more
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 |
|---|---|---|
| traxiprodil (CP-101,606) | Drug | – |
Primary outcome
No or minimal neurological deficit at last visit
Marked neurological improvement at last visit
3 secondary outcomes
Modified Rankin scale at last visit
Mortality
Safety assessments
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 22 Jun 2006.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Pfizer CT.gov Call Center study director
Pfizer
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing traxiprodil (CP-101,606) in people with Stroke, run by Pfizer at 29 sites in 8 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 4 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 22 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, Spain, Hungary, Italy and 3 more countries. 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?
No or minimal neurological deficit at last visit. The study lists 2 primary outcomes in all. 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 22 Jun 2006.