HyperlipidemiaPhase 3NCT00267280
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).
A Phase 3 study testing torcetrapib/atorvastatin and simvastatin in people with Hyperlipidemia and Dyslipidemia, run by Pfizer at 51 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
- 51 sitesUnited States
- Study dates
- Jan 2006to 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
- 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
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Pfizer Investigational Site
Albany, New York
Pfizer Investigational Site
Alhambra, California
Pfizer Investigational Site
Atlanta, Georgia
Pfizer Investigational Site
Baltimore, Maryland
Pfizer Investigational Site
Beaver, Pennsylvania
Pfizer Investigational Site
Bellevue, Washington
Pfizer Investigational Site
Bethesda, Maryland
Pfizer Investigational Site
Birmingham, Alabama
Pfizer Investigational Site
Charlotte, North Carolina
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Collierville, Tennessee
Pfizer Investigational Site
Conyers, Georgia
Pfizer Investigational Site
Elkton, Maryland
Pfizer Investigational Site
Flint, Michigan
Pfizer Investigational Site
Flourtown, Pennsylvania
Pfizer Investigational Site
Fort Lauderdale, Florida
Pfizer Investigational Site
Greenville, South Carolina
Pfizer Investigational Site
Hillsboro, Oregon
Pfizer Investigational Site
Hinsdale, Illinois
Pfizer Investigational Site
Hollywood, Florida
Pfizer Investigational Site
Inglewood, California
Pfizer Investigational Site
Jacksonville, Florida
Pfizer Investigational Site
Kansas City, Kansas
Pfizer Investigational Site
Kingsport, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee
Pfizer Investigational Site
La Grange, Illinois
Pfizer Investigational Site
Lawrenceville, New Jersey
Pfizer Investigational Site
Lexington, Kentucky
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Mansfield, Ohio
Pfizer Investigational Site
Merritt Island, Florida
Pfizer Investigational Site
Mesa, Arizona
Pfizer Investigational Site
North Richland Hills, Texas
Pfizer Investigational Site
Park Ridge, Illinois
Pfizer Investigational Site
Pensacola, Florida
Pfizer Investigational Site
Philadelphia, Pennsylvania
Pfizer Investigational Site
Puyallup, Washington
Pfizer Investigational Site
Richmond, Virginia
Pfizer Investigational Site
Salt Lake City, Utah
Pfizer Investigational Site
Santa Ana, California
Pfizer Investigational Site
Seaford, New York
Pfizer Investigational Site
Spring, Texas
Pfizer Investigational Site
Springfield, Illinois
Pfizer Investigational Site
Springfield, Missouri
Pfizer Investigational Site
Tacoma, Washington
Pfizer Investigational Site
Vero Beach, Florida
Pfizer Investigational Site
West Jordan, Utah
Pfizer Investigational Site
Wilmington, Delaware
Pfizer Investigational Site
Winter Park, Florida
Pfizer Investigational Site
Woodstock, Georgia
Pfizer Investigational Site
Yardley, Pennsylvania
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 (A5091031)
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
- 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 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)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267280
- Sponsor's protocol ID
- A5091031
- Status last verified
- Feb 2012
- First submitted
- 19 Dec 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
- 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 (A5091031)
- ClinicalTrials.gov ID
- NCT00267280
- Acronym / sponsor ID
- A5091031
- Conditions
- Hyperlipidemia, Dyslipidemia, Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 640 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 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 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
51 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 51 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: 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 51 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 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?
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 17 Feb 2012.