Cardiovascular DiseaseNCT00452842
Safety FollowUp Study Of Cardiovascular Events In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Studies
An observational study of Cardiovascular Disease and Cerebrovascular Disorders, run by Pfizer at 1 site in United States.
Trial summary
An observational safety follow up trial will be conducted to monitor the occurrence of cardiovascular events and all cause mortality in subjects who participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials. No hypotheses will be tested. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cardiovascular Disease, Cerebrovascular Disorders
- How many people
- 26,784 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to not given
- Phase
- Observational
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have signed informed consent prior to the initiation of any study-specific activities.
- Have participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials and were treated with randomized study medication.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Clearwater, Florida, 33756
About this study
Official title: An Observational Safety Follow Up Trial Of The Occurrence Of Major Cardiovascular Events And All Cause Mortality In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Clinical Trials.
An observational safety follow up trial will be conducted to monitor the occurrence of cardiovascular events and all cause mortality in subjects who participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials. No hypotheses will be tested.
Read the detailed description
Study A5091075, an observational study in subjects who had previously been treated with torcetrapib, was terminated on 20 Dec 2007. The study was terminated following reviews of final safety information from prior torcetrapib studies and the low participation rates observed during the recruitment period for study A5091075 . On the basis of this new information the Sponsor determined that it was unlikely that this study would result in new and scientifically valid information.
- Conditions
- Cardiovascular Disease, Cerebrovascular Disorders
- Medical subject headings
- Cardiovascular Diseases, Cerebrovascular Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startOct 2007
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Observational
- Enrolment
- 26,784 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
- NCT00452842
- Sponsor's protocol ID
- A5091075
- Status last verified
- Dec 2007
- First submitted
- 26 Mar 2007
- Last updated
- 22 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Safety Follow Up Trial Of The Occurrence Of Major Cardiovascular Events And All Cause Mortality In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Clinical Trials.
- ClinicalTrials.gov ID
- NCT00452842
- Acronym / sponsor ID
- A5091075
- Conditions
- Cardiovascular Disease, Cerebrovascular Disorders
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 26,784 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- First posted
- 28 Mar 2007 (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.
An observational safety follow up trial will be conducted to monitor the occurrence of cardiovascular events and all cause mortality in subjects who participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials. No hypotheses will be tested.
Detailed description
Study A5091075, an observational study in subjects who had previously been treated with torcetrapib, was terminated on 20 Dec 2007. The study was terminated following reviews of final safety information from prior torcetrapib studies and the low participation rates observed during the recruitment period for study A5091075 . On the basis of this new information the Sponsor determined that it was unlikely that this study would result in new and scientifically valid information.
Study design
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Have signed informed consent prior to the initiation of any study-specific activities.
- Have participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials and were treated with randomized study medication.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Cerebrovascular Disorders, run by Pfizer at 1 site in United States.
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 1 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 Feb 2008. 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 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.
Are results available for this study?
The study was stopped early (reason given: See termination reason in detailed description.). 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.
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 Feb 2008.