Hypercholesterolemia, FamilialPhase 3NCT00134485
Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
A Phase 3 study testing torcetrapib/atorvastatin and atorvastatin in people with Hypercholesterolemia, Familial and Hyperlipidemia, run by Pfizer at 41 sites in 10 countries.
Trial summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Familial, Hyperlipidemia
- What is being tested?
- torcetrapib/atorvastatin and atorvastatin
- How many people
- 400 participants
- Where
- 41 sitesin 10 countries
- Study dates
- Mar 2005to Mar 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 Heterozygous Familial Hypercholesterolemia
- At least 18 years of age
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 (high doses)
- 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
41 sites in 10 countries.
41 sites in 10 countries
United States14 sites
Pfizer Investigational Site
Auburn, Maine, 04210
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Charlotte, North Carolina, 28204
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Lutz, Florida, 33549
Pfizer Investigational Site
Madison, Wisconsin, 53719
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
Scarborough, Maine, 04074
Pfizer Investigational Site
Tampa, Florida, 33603
Pfizer Investigational Site
Tripler AMC, Hawaii, 96859-5000
Pfizer Investigational Site
Washington D.C., District of Columbia, 20037
Australia6 sites
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
Darlinghurst, NSW 2010
Pfizer Investigational Site
North Adelaide, South Australia, 5006
Pfizer Investigational Site
Perth, Western Australia, 6000
Pfizer Investigational Site
Woolloongabba, Queensland, 4102
Canada4 sites
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Montreal, Quebec, H1T 1C8
Pfizer Investigational Site
Montreal, Quebec, H2W 1R7
Pfizer Investigational Site
Ste-Foy, Quebec, G1V 4M6
South Africa4 sites
Pfizer Investigational Site
Bellville, Western Cape, 7531
Pfizer Investigational Site
Bloemfontein, 9301
Pfizer Investigational Site
Cape Town, 7925
Pfizer Investigational Site
Parow, Cape Town, 7500
Sweden4 sites
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Malmö, 205 02
Pfizer Investigational Site
Stockholm, 141 86
France3 sites
Pfizer Investigational Site
Dijon, 21000
Pfizer Investigational Site
Nantes, 44093
Pfizer Investigational Site
Paris, 75651 Cedex 13
Denmark2 sites
Pfizer Investigational Site
Aalborg, 9000
Pfizer Investigational Site
Arhus C, 8000
Norway2 sites
Pfizer Investigational Site
Oslo, 0027
Pfizer Investigational Site
Oslo, 0407
Location not given1 site
Pfizer Investigational Site
About this study
Official title: Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia
Read the detailed description
For additional information please call: 1-800-718-1021
- Conditions
- Hypercholesterolemia, Familial, Hyperlipidemia
- Being tested
- torcetrapib/atorvastatin, atorvastatin
- Medical subject headings
- Hyperlipoproteinemia Type II, Hyperlipidemias
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 LDL-C
Secondary outcomes (1)
Changes in 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 posted24 Aug 2005 (estimated)
- Study startMar 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia, FamilialStudies 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
- 400 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
- NCT00134485
- Sponsor's protocol ID
- A5091026
- Status last verified
- Dec 2006
- First submitted
- 22 Aug 2005
- Last updated
- 30 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00134485
- Acronym / sponsor ID
- A5091026
- Conditions
- Hypercholesterolemia, Familial, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Mar 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 evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia
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 (2 listed)
- Diagnosis of Heterozygous Familial Hypercholesterolemia
- At least 18 years of age
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 (high doses)
- 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 LDL-C
1 secondary outcome
Changes in 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 30 Oct 2007.
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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
41 sites in 10 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 Hypercholesterolemia, Familial and Hyperlipidemia, run by Pfizer at 41 sites in 10 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 2 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 30 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Australia, Canada, South Africa, Sweden and 4 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?
Change in HDL-C and LDL-C. 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 30 Oct 2007.