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Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder

Primary Purpose

Hypercholesterolemia, Familial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Torcetrapib/atorvastatin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia, Familial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Change in LDL-C and HDL-C

Secondary Outcome Measures

Other lipid variables

Full Information

First Posted
August 22, 2005
Last Updated
November 5, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00134511
Brief Title
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
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
Detailed Description
For additional information please call: 1-800-718-1021

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Familial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Torcetrapib/atorvastatin
Primary Outcome Measure Information:
Title
Change in LDL-C and HDL-C
Secondary Outcome Measure Information:
Title
Other lipid variables

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Parktown
State/Province
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa

12. IPD Sharing Statement

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Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder

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