Hyperlipoproteinemia Type IIIPhase 3NCT00145431
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.
A Phase 3 study testing torcetrapib/atorvastatin, atorvastatin and fenofibrate in people with Hyperlipoproteinemia Type III, run by Pfizer at 27 sites in 2 countries.
Trial summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipoproteinemia Type III
- What is being tested?
- torcetrapib/atorvastatin, atorvastatin and fenofibrate
- How many people
- 41 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Mar 2005to Dec 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
- Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)
Who cannot join
- Women who are pregnant or lactating, or planning to become pregnant.
- Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid
- 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
27 sites in 2 countries.
27 sites in 2 countries
United States22 sites
Pfizer Investigational Site
Anaheim, California, 92804
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Huntington Beach, California, 92648
Pfizer Investigational Site
Longwood, Florida, 32779
Pfizer Investigational Site
Madison, Wisconsin, 53719
Pfizer Investigational Site
Memphis, Tennessee, 38105
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Pacific Palisades, California, 90272
Pfizer Investigational Site
Portage, Michigan, 49002
Pfizer Investigational Site
Portage, Michigan, 49024
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Salt Lake City, Utah, 84108
Pfizer Investigational Site
Scarborough, Maine, 04074
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Studio City, California, 91604
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Tripler Army Medical Center, Hawaii, 96859-5000
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
West Seneca, New York, 14224
Canada5 sites
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
London, Ontario, N6A 5K8
Pfizer Investigational Site
Montreal, Quebec, H1T 1C8
Pfizer Investigational Site
Montreal, Quebec, H2W 1R7
Pfizer Investigational Site
Québec, Quebec, G1V 4M6
About this study
Official title: Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.
Read the detailed description
For additional information please call: 1-800-718-1021
- Conditions
- Hyperlipoproteinemia Type III
- Being tested
- torcetrapib/atorvastatin, atorvastatin, fenofibrate
- Medical subject headings
- Hyperlipoproteinemia Type III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
torcetrapib/atorvastatinDrug
atorvastatinDrug
fenofibrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-C and non-HDL-C levels.
Secondary outcomes (1)
Changes in other lipid and biomarker variable levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipoproteinemia Type IIIStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145431
- Sponsor's protocol ID
- A5091024
- Status last verified
- Feb 2012
- First submitted
- 31 Aug 2005
- Last updated
- 17 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).
- ClinicalTrials.gov ID
- NCT00145431
- Acronym / sponsor ID
- A5091024
- Conditions
- Hyperlipoproteinemia Type III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 5 Sep 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 evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.
Detailed description
For additional information please call: 1-800-718-1021
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)
Key exclusion criteria (4 listed)
- Women who are pregnant or lactating, or planning to become pregnant.
- Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid
- 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 | – |
| fenofibrate | Drug | – |
Primary outcome
Change in LDL-C and non-HDL-C levels.
1 secondary outcome
Changes in other lipid and biomarker variable levels.
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 17 Feb 2012.
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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
27 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, atorvastatin and fenofibrate in people with Hyperlipoproteinemia Type III, run by Pfizer at 27 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 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: stopped early, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 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?
Change in LDL-C and non-HDL-C levels.. 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 17 Feb 2012.