Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00134485 |
Date of registration:
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22/08/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
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Scientific title:
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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 |
Date of first enrolment:
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March 2005 |
Target sample size:
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400 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00134485 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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Denmark
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France
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Iceland
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Norway
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South Africa
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Sweden
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Heterozygous Familial Hypercholesterolemia
- At least 18 years of age
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 (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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypercholesterolemia, Familial
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Hyperlipidemia
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Intervention(s)
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Drug: atorvastatin
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Drug: torcetrapib/atorvastatin
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Primary Outcome(s)
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Change in HDL-C and LDL-C
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Secondary Outcome(s)
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Changes in other lipid parameters
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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