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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00137462
Enrollment
900
Registered
2005-08-29
Start date
2004-11-30
Completion date
2006-09-30
Last updated
2007-11-16

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

Detailed description

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

Interventions

DRUGatorvastatin

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Changes in levels of lipids and other biomarkers.

Countries

Canada, United States

Outcome results

None listed

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