HyperlipidemiaPhase 3NCT00138762
A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol
A Phase 3 study testing torcetrapib/atorvastatin and atorvastatin in people with Hyperlipidemia, run by Pfizer at 154 sites in 8 countries.
Trial summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,800 participants
- Where
- 154 sitesin 8 countries
- Study dates
- Jul 2004to 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
- subjects with elevated cholesterol
Who cannot join
- Women who are pregnant or lactating, or planning to become pregnant.
- Intolerance to statin therapy resulting in withdrawal
- 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
154 sites in 8 countries.
154 sites in 8 countries
United States96 sites
Pfizer Investigational Site
Anaheim, California
Pfizer Investigational Site
Austin, Texas
Pfizer Investigational Site
Baltimore, Maryland
Pfizer Investigational Site
Beaumont, Texas
Pfizer Investigational Site
Beaverton, Oregon
Pfizer Investigational Site
Bethesda, Maryland
Pfizer Investigational Site
Billings, Montana
Pfizer Investigational Site
Boulder, Colorado
Pfizer Investigational Site
Bryan, Texas
Pfizer Investigational Site
Carmichael, California
Pfizer Investigational Site
Charlotte, North Carolina
Pfizer Investigational Site
Chicago, Illinois
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Concord, California
Pfizer Investigational Site
Concord, North Carolina
Pfizer Investigational Site
Coral Gables, Florida
Pfizer Investigational Site
Covington, Louisiana
Pfizer Investigational Site
Creve Coevr, Illinois
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
Elkton, Maryland
Pfizer Investigational Site
Elyria, Ohio
Pfizer Investigational Site
Endwell, New York
Pfizer Investigational Site
Erlanger, Kentucky
Pfizer Investigational Site
Fayetteville, North Carolina
Pfizer Investigational Site
Ft. Pierce, Florida
Pfizer Investigational Site
Greenbrae, California
Pfizer Investigational Site
Greer, South Carolina
Pfizer Investigational Site
Hillsboro, Oregon
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Iowa City, Iowa
Pfizer Investigational Site
Jackson, Mississippi
Pfizer Investigational Site
Jacksonville, Florida
Pfizer Investigational Site
Jefferson City, Missouri
Pfizer Investigational Site
Jupiter, Florida
Pfizer Investigational Site
Kansas City, Kansas
Pfizer Investigational Site
Kansas City, Missouri
Pfizer Investigational Site
Kingsport, Tennessee
Pfizer Investigational Site
Lake Success, New York
Pfizer Investigational Site
Lake Worth, Florida
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
Louisville, Kentucky
Pfizer Investigational Site
Melbourne, Florida
Pfizer Investigational Site
Mesa, Arizona
Pfizer Investigational Site
Milwaukee, Wisconsin
Pfizer Investigational Site
Mission Viejo, California
Pfizer Investigational Site
Mobile, Alabama
Pfizer Investigational Site
Monroe, North Carolina
Pfizer Investigational Site
Nashville, Tennessee
Pfizer Investigational Site
Newark, Delaware
Pfizer Investigational Site
Newport News, Virginia
Pfizer Investigational Site
Norfolk, Virginia
Pfizer Investigational Site
Olmsted, Ohio
Pfizer Investigational Site
Omaha, Nebraska
Pfizer Investigational Site
Oregon, Wisconsin
Pfizer Investigational Site
Oro Valley, Arizona
Pfizer Investigational Site
Overland Park, Kansas
Pfizer Investigational Site
Palm Bay, Florida
Pfizer Investigational Site
Peoria, Illinois
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Raleigh, North Carolina
Pfizer Investigational Site
Renton, Washington
Pfizer Investigational Site
Richmond, Virginia
Pfizer Investigational Site
Rochester, New York
Pfizer Investigational Site
Rockford, Illinois
Pfizer Investigational Site
Sacramento, California
Pfizer Investigational Site
Salt Lake City, Utah
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
Santa Ana, California
Pfizer Investigational Site
Scarborough, Maine
Pfizer Investigational Site
Sebastian, Florida
Pfizer Investigational Site
Slidell, Louisiana
Pfizer Investigational Site
Spartanburg, South Carolina
Pfizer Investigational Site
Stockton, California
Pfizer Investigational Site
Stuart, Florida
Pfizer Investigational Site
Sun City, Arizona
Pfizer Investigational Site
The Colony, Texas
Pfizer Investigational Site
Thouasand Oaks, California
Pfizer Investigational Site
Tulsa, Oklahoma
Pfizer Investigational Site
Tustin, California
Pfizer Investigational Site
Upland, California
Pfizer Investigational Site
Vero Beach, Florida
Pfizer Investigational Site
Walnut Creek, California
Pfizer Investigational Site
Warwick, Rhode Island
Pfizer Investigational Site
Waterbury, Connecticut
Pfizer Investigational Site
Wellington, Florida
Pfizer Investigational Site
West Palm Beach, Florida
Pfizer Investigational Site
Westlake, Ohio
Pfizer Investigational Site
Westlake Village, California
Pfizer Investigational Site
Wichita, Kansas
Pfizer Investigational Site
Williamsville, New York
Pfizer Investigational Site
Winston-Salem, North Carolina
Pfizer Investigational Site
Yakima, Washington
Germany15 sites
Pfizer Investigational Site
Beckum
Pfizer Investigational Site
Berlin
Pfizer Investigational Site
Bochum
Pfizer Investigational Site
Erlangen
Pfizer Investigational Site
Essen
Pfizer Investigational Site
Feldafing
Pfizer Investigational Site
Hamburg
Pfizer Investigational Site
Heidelberg
Pfizer Investigational Site
Homburg/Saar
Pfizer Investigational Site
Karlsruhe
Pfizer Investigational Site
Künzing
Pfizer Investigational Site
Nuremberg
Pfizer Investigational Site
Offenbach
Pfizer Investigational Site
Rodgau
Pfizer Investigational Site
Schwerin
Norway13 sites
Pfizer Investigational Site
Bekkestua
Pfizer Investigational Site
Elverum
Pfizer Investigational Site
Hønefoss
Pfizer Investigational Site
Jessheim
Pfizer Investigational Site
Kongsberg
Pfizer Investigational Site
Lena
Pfizer Investigational Site
Lierskogen
Pfizer Investigational Site
Molde
Pfizer Investigational Site
Moss
Pfizer Investigational Site
Oslo
Pfizer Investigational Site
Roverud
Pfizer Investigational Site
Skedsmokorset
Pfizer Investigational Site
Tromsø
United Kingdom9 sites
Pfizer Investigational Site
Addlestone, Surrey
Pfizer Investigational Site
Blackpool, Lancashire
Pfizer Investigational Site
Blackpool, Lancs. Fy3 7dq
Pfizer Investigational Site
East Horsley, Leatherhead, Surrey
Pfizer Investigational Site
Garston, Hertfordshire
Pfizer Investigational Site
Middlesex, Harrow
Pfizer Investigational Site
Penzance, Cornwall
Pfizer Investigational Site
Warminster, Wiltshire
Pfizer Investigational Site
Woolwell, Plymouth, Devon
Belgium8 sites
Pfizer Investigational Site
Brussels
Pfizer Investigational Site
Dottignies
Pfizer Investigational Site
Ham
Pfizer Investigational Site
Hasselt
Pfizer Investigational Site
Hoeilaart
Pfizer Investigational Site
La Louvière
Pfizer Investigational Site
Leuven
Pfizer Investigational Site
Wilsele
Sweden6 sites
Pfizer Investigational Site
Gothenburg
Pfizer Investigational Site
Jarfalla
Pfizer Investigational Site
Linköping
Pfizer Investigational Site
Örebro
Pfizer Investigational Site
Strängnäs
Pfizer Investigational Site
Umeå
Mexico5 sites
Pfizer Investigational Site
México, D.f.
Pfizer Investigational Site
Mexico City, Mexico City
Pfizer Investigational Site
Monterrey, Nuevo León
Pfizer Investigational Site
Puebla City, Puebla
Pfizer Investigational Site
Tlalpan, D.f.
South Korea2 sites
Pfizer Investigational Site
Seoul
Pfizer Investigational Site
Suwon
About this study
Official title: A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.
Read the detailed description
For additional information please call: 1-800-718-1021
- Conditions
- Hyperlipidemia
- Being tested
- torcetrapib/atorvastatin, atorvastatin, placebo
- 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
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL and HDL levels
Secondary outcomes (1)
other lipid parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionAug 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
- Double blind
- Enrolment
- 3,800 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
- NCT00138762
- Sponsor's protocol ID
- A5091018
- Status last verified
- Feb 2012
- First submitted
- 26 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
- A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).
- ClinicalTrials.gov ID
- NCT00138762
- Acronym / sponsor ID
- A5091018
- Conditions
- Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,800 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 30 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.
A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.
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)
- subjects with elevated cholesterol
Key exclusion criteria (4 listed)
- Women who are pregnant or lactating, or planning to become pregnant.
- Intolerance to statin therapy resulting in withdrawal
- 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 | – |
| placebo | Drug | – |
Primary outcome
LDL and HDL levels
1 secondary outcome
other lipid parameters
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 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
154 sites in 8 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 154 sites in 8 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 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 154 sites in United States, Germany, Norway, United Kingdom, Belgium and 3 more countries. 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?
LDL and HDL 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.