- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00134511
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder
November 5, 2007 updated by: Pfizer
Phase 3 Multi-Center, Open Label, Forced Titration Study To Evaluate The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Combination Administered Orally, Once Daily (Qd) In Patients With Homozygous Familial Hypercholesterolaemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For additional information please call: 1-800-718-1021
Study Type
Interventional
Enrollment
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- Pfizer Investigational Site
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Ste-Foy, Quebec, Canada, G1V 4M6
- Pfizer Investigational Site
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Bloemfontein, South Africa, 9301
- Pfizer Investigational Site
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Cape Town, South Africa, 7925
- Pfizer Investigational Site
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Johannesburg
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Parktown, Johannesburg, South Africa, 2193
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of Homozygous Familial Hypercholesterolemia
Exclusion Criteria:
- 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
- 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 evaluationof response, or render unlikely that the subject would complete the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in LDL-C and HDL-C
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Secondary Outcome Measures
Outcome Measure |
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Other lipid variables
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
August 22, 2005
First Submitted That Met QC Criteria
August 22, 2005
First Posted (Estimate)
August 24, 2005
Study Record Updates
Last Update Posted (Estimate)
November 7, 2007
Last Update Submitted That Met QC Criteria
November 5, 2007
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Hypercholesterolemia
- Hyperlipoproteinemia Type II
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Torcetrapib
Other Study ID Numbers
- A5091027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolemia, Familial
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National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
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Regeneron PharmaceuticalsSanofiTerminatedHeterozygous Familial Hypercholesterolemia | Non-familial HypercholesterolemiaUnited States, Bulgaria, Estonia, Russian Federation, South Africa, Ukraine
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Merck Sharp & Dohme LLCTerminatedHypercholesterolemia, Familial | Heterozygous Familial Hypercholesterolemia
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Institut Investigacio Sanitaria Pere VirgiliRecruitingFamilial Hypercholesterolemia | Familial Hypercholesterolemia - Homozygous | Familial Hypercholesterolemia - HeterozygousSpain
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Novartis PharmaceuticalsActive, not recruitingFamilial Hypercholesterolemia - HomozygousGreece, Lebanon, Turkey, France, Canada, Malaysia, Netherlands, United States
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Novartis PharmaceuticalsRecruitingHeterozygous or Homozygous Familial HypercholesterolemiaNetherlands, Israel, Hungary, Italy, Germany, Spain, France, Norway, South Africa, Turkey, United Kingdom, Canada, Switzerland, Brazil, Lebanon, Slovenia, United States, Russian Federation, Taiwan
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Novartis PharmaceuticalsCompletedElevated Cholesterol | Homozygous Familial Hypercholesterolemia | Heterozygous Familial Hypercholesterolemia | ASCVDUnited States, Canada, Czechia, Denmark, Germany, Hungary, Netherlands, Poland, South Africa, Spain, Sweden, Ukraine, United Kingdom
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REGENXBIO Inc.National Heart, Lung, and Blood Institute (NHLBI)TerminatedHomozygous Familial Hypercholesterolemia (HoFH)United States, Canada, Italy, Netherlands
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Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
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University of British ColumbiaVancouver Coastal Health Research Institute; Genome British ColumbiaRecruitingAcute Coronary Syndrome | Familial Hypercholesterolemia | STEMI | NSTEMI - Non-ST Segment Elevation MI | Familial Hypercholesterolemia - Heterozygous | Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B | Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation and other conditionsCanada
Clinical Trials on Torcetrapib/atorvastatin
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PfizerCompletedHypertriglyceridemia | Hyperlipoproteinemia Type IVUnited States, Canada
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PfizerCompletedCoronary Disease | Coronary Arteriosclerosis | HyperlipidemiaUnited States, Spain, Canada, Poland, Belgium, Netherlands
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PfizerTerminatedMixed HyperlipidemiaUnited States, Canada, Czech Republic, Finland, France, Netherlands
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PfizerCompletedHyperlipidemia | Hypercholesterolemia, FamilialUnited States, Canada, South Africa, Czech Republic, Italy, Finland, Netherlands, France
-
PfizerTerminatedCoronary Disease | Diabetes MellitusUnited States, Spain, Australia, Canada, Sweden, Netherlands, United Kingdom
-
PfizerCompletedHyperlipidemiaUnited States, Canada
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PfizerCompletedHyperlipidemiaUnited States, Germany, Norway, Belgium, Korea, Republic of, Mexico, Sweden, United Kingdom
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PfizerTerminatedHyperlipoproteinemia Type IIICanada, United States
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PfizerCompletedHyperlipidemia | Hypercholesterolemia, FamilialAustralia, Canada, United States, France, South Africa, Sweden, Norway, Denmark, Iceland
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PfizerCompleted