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A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

Primary Purpose

Hypertriglyceridemia, Hyperlipoproteinemia Type IV

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

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of Fredrickson Type IV Hypertriglyceridemia 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 evaluation of 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
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Change in HDL-C and non-HDL-C levels

Secondary Outcome Measures

Changes in levels of other lipid and biomarkers.

Full Information

First Posted
August 22, 2005
Last Updated
November 15, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00134498
Brief Title
A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides
Official Title
Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (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 assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.
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
Hypertriglyceridemia, Hyperlipoproteinemia Type IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
torcetrapib/atorvastatin
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Primary Outcome Measure Information:
Title
Change in HDL-C and non-HDL-C levels
Secondary Outcome Measure Information:
Title
Changes in levels of other lipid and biomarkers.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Fredrickson Type IV Hypertriglyceridemia 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 evaluation of 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
Anaheim
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Orangevale
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Pacific Palisades
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Studio City
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Tustin
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Pfizer Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Longwood
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Tripler AMC
State/Province
Hawaii
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Scarborough
State/Province
Maine
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Canton
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Portage
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Richland
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Cloud
State/Province
Minnesota
Country
United States
Facility Name
Pfizer Investigational Site
City
Olive Branch
State/Province
Mississippi
Country
United States
Facility Name
Pfizer Investigational Site
City
Jefferson City
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
West Seneca
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Statesville
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Sellersville
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chicoutimi
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-Foy
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5091025&StudyName=A+Study+Comparing+The+Efficacy+%26+Safety+Of+Torcetrapib%2FAtorvastatin+And+Atorvastatin+In+Subjects+With+High+Triglycerides
Description
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Learn more about this trial

A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

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