Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.

Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-Mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00136981

Acronym

RADIANCE 1

Enrollment

800

Registered

2005-08-29

Start date

2003-12-31

Completion date

2006-11-30

Last updated

2015-04-22

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

Conditions

Hypercholesterolemia, Familial, Hyperlipidemia

Brief summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial hypercholesterolemia

Detailed description

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

Interventions

DRUGtorcetrapib/atorvastatin

DRUGatorvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of Heterozygous Familial Hypercholesterolemia * At least 18 years of age

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 (high doses) * 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 evaluationof response, or render unlikely that the subject would complete the study

Design outcomes

Primary

Measure	Time frame
Change in intima media thickness as measures by carotid ultrasound	—

Secondary

Measure	Time frame
Changes in levels of lipids and other biomarkers.	—

Countries

Canada, Czechia, Finland, France, Italy, Netherlands, South Africa, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026