A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol

A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00138762

Enrollment

3800

Registered

2005-08-30

Start date

2004-07-31

Completion date

2006-08-31

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

Brief summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings. A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.

Detailed description

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

Interventions

DRUGtorcetrapib/atorvastatin

DRUGatorvastatin

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* subjects with elevated cholesterol

Exclusion criteria

* Women who are pregnant or lactating, or planning to become pregnant. * Intolerance to statin therapy resulting in withdrawal * 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

Design outcomes

Primary

Measure	Time frame
LDL and HDL levels	—

Secondary

Measure	Time frame
other lipid parameters	—

Countries

Belgium, Germany, Mexico, Norway, South Korea, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026