HyperlipidemiaPhase 3NCT00267267

A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.

A Phase 3 study testing torcetrapib/atorvastatin and ezetimibe/simvastatin in people with Hyperlipidemia and Dyslipidemia, run by Pfizer at 123 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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 combination 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
What is being tested?: torcetrapib/atorvastatin and ezetimibe/simvastatin
How many people: 1,784 participants
Where: 123 sitesUnited States
Study dates: Jan 2006to Jan 2007
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

Specific LDL-C levels based on CHD risk after a six-week washout period.

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 requiring systemic steroids
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

123 sites in 1 country.

City, postcode or hospital

123 sites in 1 country

United States123 sites

Pfizer Investigational Site
Anaheim, California, 92804
Pfizer Investigational Site
Anderson, South Carolina, 29621
Pfizer Investigational Site
Arlington, Texas, 76017
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Atlantis, Florida, 33462
Pfizer Investigational Site
Aurora, Illinois, 60504
Pfizer Investigational Site
Ayer, Massachusetts, 01432
Pfizer Investigational Site
Beaver, Pennsylvania, 15009
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020
Pfizer Investigational Site
Birmingham, Alabama, 35209-7802
Pfizer Investigational Site
Birmingham, Alabama, 35235
Pfizer Investigational Site
Bloomfield Hills, Michigan, 48302
Pfizer Investigational Site
Boca Raton, Florida, 33486
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Bountiful, Utah, 84010
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Brooklyn Center, Minnesota, 55430
Pfizer Investigational Site
Cary, North Carolina, 27511
Pfizer Investigational Site
Chandler, Arizona, 85224
Pfizer Investigational Site
Charlotte, North Carolina, 28209-3734
Pfizer Investigational Site
Chattanooga, Tennessee, 37404
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Columbia, Maryland, 21044-2914
Pfizer Investigational Site
Columbia, Missouri, 65212
Pfizer Investigational Site
Cooperstown, New York, 13326
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
DeFuniak Springs, Florida, 32435
Pfizer Investigational Site
Des Moines, Iowa, 50314
Pfizer Investigational Site
Destin, Florida, 32541
Pfizer Investigational Site
Doylestown, Pennsylvania, 18901
Pfizer Investigational Site
Edgewood, Kentucky, 41017
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Endwell, New York, 13760
Pfizer Investigational Site
Erlanger, Kentucky, 41018
Pfizer Investigational Site
Escondido, California, 92025-4284
Pfizer Investigational Site
Evansville, Indiana, 47712
Pfizer Investigational Site
Evansville, Indiana, 47713
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Fairview Park, Ohio, 44126
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Germantown, Tennessee, 38138
Pfizer Investigational Site
Golden, Colorado, 80401
Pfizer Investigational Site
Grand Rapids, Michigan, 49525
Pfizer Investigational Site
Harleysville, Pennsylvania, 19438
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Houston, Texas, 77054
Pfizer Investigational Site
Huntersville, North Carolina, 28078
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Lakeland, Florida, 33805
Pfizer Investigational Site
Lancaster, Pennsylvania, 17603
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Lewiston, New York, 14092
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Los Altos, California, 94024
Pfizer Investigational Site
Los Angeles, California, 90015
Pfizer Investigational Site
Louisville, Kentucky, 40205-3374
Pfizer Investigational Site
Manchester, Missouri, 63021
Pfizer Investigational Site
Manlius, New York, 13104
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Memphis, Tennessee, 38128
Pfizer Investigational Site
Mesa, Arizona, 85201
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Miami, Florida, 33144
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Monroe, North Carolina, 28112
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
New Haven, Connecticut, 06519-1600
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Newport News, Virginia, 23606
Pfizer Investigational Site
Newton, Kansas, 67114
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Omaha, Nebraska, 68106
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Omaha, Nebraska, 68130
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Palm Springs, California, 92262
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Pensacola, Florida, 32504-8721
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15224
Pfizer Investigational Site
Pratt, Kansas, 67124
Pfizer Investigational Site
Providence, Rhode Island, 02906
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Renton, Washington, 98055
Pfizer Investigational Site
Rochester, New York, 14609
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Rockford, Illinois, 61108
Pfizer Investigational Site
Saint Cloud, Minnesota, 56303-1901
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78238
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
Santa Rose, California, 95405
Pfizer Investigational Site
Sayre, Pennsylvania, 18840
Pfizer Investigational Site
Selmer, Tennessee, 38375
Pfizer Investigational Site
Simpsonville, South Carolina, 29681
Pfizer Investigational Site
Spokane, Washington, 99216
Pfizer Investigational Site
Springfield, Illinois, 62701
Pfizer Investigational Site
Springfield, Missouri, 65804
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
Syracuse, New York, 13202
Pfizer Investigational Site
Topeka, Kansas, 66606
Pfizer Investigational Site
Troy, Michigan, 48098
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
West Seneca, New York, 14224
Pfizer Investigational Site
Westlake Village, California, 91361
Pfizer Investigational Site
Wilmington, North Carolina, 28412
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103-3315
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects With Dyslipidemia.

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 combination 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
Being tested: torcetrapib/atorvastatin, ezetimibe/simvastatin
Medical subject headings: Hyperlipidemias, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

torcetrapib/atorvastatinDrug
ezetimibe/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.

Jan 2006Jan 2007

First posted20 Dec 2005 (estimated)
Study startJan 2006
Study completionJan 2007

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: 1,784 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00267267
Sponsor's protocol ID: A5091035
Status last verified: Dec 2006
First submitted: 19 Dec 2005
Last updated: 10 Dec 2007
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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Cardiovascular Diseases, Hypertension
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia

All Hyperlipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects With Dyslipidemia.
ClinicalTrials.gov ID: NCT00267267
Acronym / sponsor ID: A5091035
Conditions: Hyperlipidemia, Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 1,784 participants
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2006
Study completion: Jan 2007 (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.

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)

Specific LDL-C levels based on CHD risk after a six-week washout period.

Key exclusion criteria (4 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 requiring systemic steroids
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	–
ezetimibe/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 10 Dec 2007.

Related trials for Hyperlipidemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia

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

123 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 ezetimibe/simvastatin in people with Hyperlipidemia and Dyslipidemia, run by Pfizer at 123 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 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 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 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?

On the ClinicalTrials.gov record for NCT00267267.

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 10 Dec 2007.