HyperlipidemiaPhase 3NCT00137462
Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.
A Phase 3 study testing torcetrapib/atorvastatin and atorvastatin in people with Hyperlipidemia, run by Pfizer at 59 sites in 2 countries.
Trial summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- torcetrapib/atorvastatin and atorvastatin
- How many people
- 900 participants
- Where
- 59 sitesin 2 countries
- Study dates
- Nov 2004to Sep 2006
- Phase
- Phase 3
- 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
- Statin eligible per NCEP ATP-III guidelines
- At least 18 years of age
Who cannot join
- Women who are pregnant or lactating, or planning to become pregnant
- Intolerance to statin therapy
- Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
- Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study
Trial locations and contacts
59 sites in 2 countries.
59 sites in 2 countries
United States48 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Albuquerque, New Mexico, 87106
Pfizer Investigational Site
Boynton Beach, Florida, 33437
Pfizer Investigational Site
Bridgeport, Connecticut, 06610
Pfizer Investigational Site
Burlington, Massachusetts, 01805
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Charlotte, North Carolina, 28262
Pfizer Investigational Site
Cleveland, Ohio, 44126
Pfizer Investigational Site
Columbus, Ohio, 43214
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Denver, Colorado, 80262
Pfizer Investigational Site
Doylestown, Pennsylvania, 18901
Pfizer Investigational Site
Fairfield, Connecticut, 06824
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Gainesville, Florida, 32605
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Gainsville, Florida, 32610
Pfizer Investigational Site
Golden, Colorado, 80401
Pfizer Investigational Site
Grand Rapids, Michigan, 49525
Pfizer Investigational Site
Huntsville, Alabama, 35802
Pfizer Investigational Site
Keizer, Oregon, 97303
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Los Angeles, California, 90057
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
McKinney, Texas, 75069
Pfizer Investigational Site
Morristown, Tennessee, 37813
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 83464
Pfizer Investigational Site
Olathe, Kansas, 66061
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Orchard Park, New York, 14127
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Rockford, Illinois, 61108
Pfizer Investigational Site
Salem, Oregon, 97302
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
Sebastian, Florida, 32958
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
Syracuse, New York, 13202
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Troy, Michigan, 48098
Pfizer Investigational Site
Trumbull, Connecticut, 06611
Pfizer Investigational Site
Union Grove, Alabama, 35175
Pfizer Investigational Site
Vero Beach, Florida, 32960
Pfizer Investigational Site
Washington D.C., District of Columbia, 20037
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Williamsville, New York, 14221
Canada11 sites
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1A 1L2
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7
Pfizer Investigational Site
London, Ontario, N6C 5J1
Pfizer Investigational Site
London, Ontario, N6G 2M3
Pfizer Investigational Site
Mirabel, Quebec, J7J 2K8
Pfizer Investigational Site
Ottawa, Ontario, K1H 8K7
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Saint Georges de Beauce, Quebec, G5Y 4W1
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
About this study
Official title: A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias
Read the detailed description
For additional information please call: 1-800-718-1021
- Conditions
- Hyperlipidemia
- Being tested
- torcetrapib/atorvastatin, atorvastatin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
torcetrapib/atorvastatinDrug
atorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.
Secondary outcomes (1)
Changes in levels of lipids and other biomarkers.
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 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 900 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
- NCT00137462
- Sponsor's protocol ID
- A5091019
- Status last verified
- Dec 2006
- First submitted
- 26 Aug 2005
- Last updated
- 16 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias
- ClinicalTrials.gov ID
- NCT00137462
- Acronym / sponsor ID
- A5091019
- Conditions
- Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Sep 2006
- 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 Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias
Detailed description
For additional information please call: 1-800-718-1021
Study design
- Primary purpose
- Treatment
- 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 (2 listed)
- Statin eligible per NCEP ATP-III guidelines
- At least 18 years of age
Key exclusion criteria (4 listed)
- Women who are pregnant or lactating, or planning to become pregnant
- Intolerance to statin therapy
- Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
- Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study
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 |
|---|---|---|
| torcetrapib/atorvastatin | Drug | – |
| atorvastatin | Drug | – |
Primary outcome
Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.
1 secondary outcome
Changes in levels of lipids and other biomarkers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 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.
Pfizer CT.gov Call Center study director
Pfizer
59 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing torcetrapib/atorvastatin and atorvastatin in people with Hyperlipidemia, run by Pfizer at 59 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 2 inclusion and 4 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 16 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.. 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 16 Nov 2007.