A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091031)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00267280

Enrollment

640

Registered

2005-12-20

Start date

2006-01-31

Completion date

2006-12-31

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

Dyslipidemia, Hypercholesterolemia, Hyperlipidemia

Brief summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Detailed description

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

Interventions

DRUGtorcetrapib/atorvastatin

DRUGsimvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion criteria

* Women who are pregnant or lactating, or planning to become pregnant. * Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors. * Subjects with significant liver or kidney disease or significant heart failure.

Design outcomes

Primary

Measure	Time frame
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.	—

Secondary

Measure	Time frame
Changes in other lipid parameters and other biomarkers.	—

Countries

United States

Outcome results

None listed

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