HypertriglyceridemiaPhase 3NCT00134498
A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides
A Phase 3 study testing torcetrapib/atorvastatin and atorvastatin in people with Hypertriglyceridemia and Hyperlipoproteinemia Type IV, run by Pfizer at 44 sites in 2 countries.
Trial summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia, Hyperlipoproteinemia Type IV
- What is being tested?
- torcetrapib/atorvastatin and atorvastatin
- How many people
- 160 participants
- Where
- 44 sitesin 2 countries
- Study dates
- Feb 2005to Nov 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 Fredrickson Type IV Hypertriglyceridemia
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
44 sites in 2 countries.
44 sites in 2 countries
United States39 sites
Pfizer Investigational Site
Anaheim, California
Pfizer Investigational Site
Ann Arbor, Michigan
Pfizer Investigational Site
Baton Rouge, Louisiana
Pfizer Investigational Site
Bethesda, Maryland
Pfizer Investigational Site
Canton, Michigan
Pfizer Investigational Site
Chicago, Illinois
Pfizer Investigational Site
Farmington, Connecticut
Pfizer Investigational Site
Hollywood, Florida
Pfizer Investigational Site
Huntington Beach, California
Pfizer Investigational Site
Indianapolis, Indiana
Pfizer Investigational Site
Jefferson City, Missouri
Pfizer Investigational Site
Las Vegas, Nevada
Pfizer Investigational Site
Longwood, Florida
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Madison, Wisconsin
Pfizer Investigational Site
Olive Branch, Mississippi
Pfizer Investigational Site
Orange, California
Pfizer Investigational Site
Orangevale, California
Pfizer Investigational Site
Overland Park, Kansas
Pfizer Investigational Site
Pacific Palisades, California
Pfizer Investigational Site
Portage, Michigan
Pfizer Investigational Site
Richland, Michigan
Pfizer Investigational Site
Richmond, Virginia
Pfizer Investigational Site
Rochester, New York
Pfizer Investigational Site
Saint Cloud, Minnesota
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
Scarborough, Maine
Pfizer Investigational Site
Sellersville, Pennsylvania
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
Statesville, North Carolina
Pfizer Investigational Site
Studio City, California
Pfizer Investigational Site
Syracuse, New York
Pfizer Investigational Site
Tripler AMC, Hawaii
Pfizer Investigational Site
Tustin, California
Pfizer Investigational Site
Walnut Creek, California
Pfizer Investigational Site
Warwick, Rhode Island
Pfizer Investigational Site
Washington D.C., District of Columbia
Pfizer Investigational Site
West Palm Beach, Florida
Pfizer Investigational Site
West Seneca, New York
Canada5 sites
Pfizer Investigational Site
Chicoutimi, Quebec
Pfizer Investigational Site
Halifax, Nova Scotia
Pfizer Investigational Site
London, Ontario
Pfizer Investigational Site
Montreal, Quebec
Pfizer Investigational Site
Ste-Foy, Quebec
About this study
Official title: Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.
Read the detailed description
For additional information please call: 1-800-718-1021
- Conditions
- Hypertriglyceridemia, Hyperlipoproteinemia Type IV
- Being tested
- torcetrapib/atorvastatin, atorvastatin
- Medical subject headings
- Hypertriglyceridemia, Hyperlipoproteinemia Type IV
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 HDL-C and non-HDL-C levels
Secondary outcomes (1)
Changes in levels of other lipid and biomarkers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startFeb 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- 160 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
- NCT00134498
- Sponsor's protocol ID
- A5091025
- Status last verified
- Mar 2007
- First submitted
- 22 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
- Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT00134498
- Acronym / sponsor ID
- A5091025
- Conditions
- Hypertriglyceridemia, Hyperlipoproteinemia Type IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Nov 2006
- First posted
- 24 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 assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.
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 (1 listed)
- Diagnosis of Fredrickson Type IV Hypertriglyceridemia
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 | – |
Primary outcome
Change in HDL-C and non-HDL-C levels
1 secondary outcome
Changes in levels of other lipid and 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.
- 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
44 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 Hypertriglyceridemia and Hyperlipoproteinemia Type IV, run by Pfizer at 44 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: 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 44 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 HDL-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 16 Nov 2007.