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OpenTrials
Completed

NCT Number: NCT00137462

Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias

Completed

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Edmonton, Alberta, Canada

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About this study

For additional information please call: 1-800-718-1021

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Statin eligible per NCEP ATP-III guidelines
  • At least 18 years of age

Exclusion criteria

  • Women who are pregnant or lactating, or planning to become pregnant
  • Intolerance to statin therapy
  • 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

Treatment and study plan

torcetrapib/atorvastatin

Drug

atorvastatin

Drug

Primary outcomes

  1. Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.

Secondary outcomes

  1. Changes in levels of lipids and other biomarkers.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias

Important dates

Study start
2004
Study completion
2006
First posted
Aug 29, 2005
Registry last updated
Nov 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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