HyperlipidemiaPhase 3NCT00267254
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.
A Phase 3 study testing torcetrapib/atorvastatin and simvastatin in people with Hyperlipidemia and Dyslipidemia, run by Pfizer at 49 sites in United States.
Trial summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia, Dyslipidemia, Hypercholesterolemia
- What is being tested?
- torcetrapib/atorvastatin and simvastatin
- How many people
- 640 participants
- Where
- 49 sitesUnited States
- Study dates
- Jan 2006to Aug 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
- eligible for statin treatment for LDL cholesterol by NCEP guidelines
Who cannot join
- Women who are pregnant or lactating, or planning to become pregnant.
- Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
- Subjects with significant liver or kidney disease or significant heart failure.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Pfizer Investigational Site
Ann Arbor, Michigan
Pfizer Investigational Site
Birmingham, Alabama
Pfizer Investigational Site
Boston, Massachusetts
Pfizer Investigational Site
Boynton Beach, Florida
Pfizer Investigational Site
Butte, Montana
Pfizer Investigational Site
Canton, Michigan
Pfizer Investigational Site
Charlotte, North Carolina
Pfizer Investigational Site
Chicago, Illinois
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Clinton, South Carolina
Pfizer Investigational Site
Concord, New Hampshire
Pfizer Investigational Site
Cooperstown, New York
Pfizer Investigational Site
Cordova, Tennessee
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
East Syracuse, New York
Pfizer Investigational Site
Fort Worth, Texas
Pfizer Investigational Site
Kansas City, Missouri
Pfizer Investigational Site
Las Vegas, Nevada
Pfizer Investigational Site
Lincoln, Nebraska
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Madisonville, Kentucky
Pfizer Investigational Site
Melbourne, Florida
Pfizer Investigational Site
Memphis, Tennessee
Pfizer Investigational Site
Merritt Island, Florida
Pfizer Investigational Site
Mesa, Arizona
Pfizer Investigational Site
Milan, Tennessee
Pfizer Investigational Site
Milwaukee, Wisconsin
Pfizer Investigational Site
Minneapolis, Minnesota
Pfizer Investigational Site
Mobile, Alabama
Pfizer Investigational Site
Newton, Kansas
Pfizer Investigational Site
Norfolk, Virginia
Pfizer Investigational Site
Palm Bay, Florida
Pfizer Investigational Site
Payson, Utah
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Portage, Michigan
Pfizer Investigational Site
Rochester, New York
Pfizer Investigational Site
Safety Harbor, Florida
Pfizer Investigational Site
Salt Lake City, Utah
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Diego, California
Pfizer Investigational Site
Santa Rosa, California
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
Tampa, Florida
Pfizer Investigational Site
Tempe, Arizona
Pfizer Investigational Site
Topeka, Kansas
Pfizer Investigational Site
Trenton, New Jersey
Pfizer Investigational Site
Troy, Michigan
Pfizer Investigational Site
Wichita, Kansas
About this study
Official title: A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091030)
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.
Read the detailed description
For additional information please call: 1-800-718-1021
- Conditions
- Hyperlipidemia, Dyslipidemia, Hypercholesterolemia
- Being tested
- torcetrapib/atorvastatin, simvastatin
- Medical subject headings
- Hyperlipidemias, Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
torcetrapib/atorvastatinDrug
simvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
Secondary outcomes (1)
Changes in other lipid parameters 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 posted20 Dec 2005 (estimated)
- Study startJan 2006
- Study completionAug 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
- None (open label)
- Enrolment
- 640 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
- NCT00267254
- Sponsor's protocol ID
- A5091030
- Status last verified
- Apr 2007
- First submitted
- 19 Dec 2005
- Last updated
- 21 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091030)
- ClinicalTrials.gov ID
- NCT00267254
- Acronym / sponsor ID
- A5091030
- Conditions
- Hyperlipidemia, Dyslipidemia, Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Aug 2006 (actual)
- First posted
- 20 Dec 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.
Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.
Detailed description
For additional information please call: 1-800-718-1021
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- eligible for statin treatment for LDL cholesterol by NCEP guidelines
Key exclusion criteria (3 listed)
- Women who are pregnant or lactating, or planning to become pregnant.
- Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
- Subjects with significant liver or kidney disease or significant heart failure.
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 | – |
| simvastatin | Drug | – |
Primary outcome
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
1 secondary outcome
Changes in other lipid parameters 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 21 Nov 2007.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Hyperlipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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RecruitingObservational study
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing torcetrapib/atorvastatin and simvastatin in people with Hyperlipidemia and Dyslipidemia, run by Pfizer at 49 sites 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 1 inclusion and 3 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 21 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 49 sites 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.
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?
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.. 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 21 Nov 2007.