RADIANCE 1
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]
Official Title
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.
Objective
The objective of this study is 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. The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
Sponsor
Pfizer
Timeline
| Timeline | |
| Start Date | December 2003 |
| End Date | November 2006 |
| Status | Terminated on December 2, 2006 due to safety findings |
The previous information was derived from ClinicalTrials.gov on 08/18/2014 using the identification number NCT00136981.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | |
| Allocation | Randomized |
| Endpoint | Safety/Efficacy Study |
| Interventional Model | Parallel Assignment |
| Masking | Double-Blind |
| Study Details | |
| Primary Purpose | Treatment |
| Condition | Hypercholesterolemia, familial hyperlipidemia |
| Intervention | Drug: torcetrapib/atorvastatin Drug: atorvastatin |
| Population Size | 800 subjects |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00136981.
Eligibility Criteria
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 evaluation of response, or render unlikely that the subject would complete the study
Outcomes
Primary Outcomes
- Change in intima media thickness as measures by carotid ultrasound
Secondary Outcomes
- Changes in levels of lipids and other biomarkers
Publications
The administration of torcetrapib with atorvastatin among patients with familial hypercholesterolemia did not lead to decrease in the progression of atherosclerosis as compared with atorvastatin alone.[1]
References
- ↑ Kastelein JJ, van Leuven SI, Burgess L, Evans GW, Kuivenhoven JA, Barter PJ; et al. (2007). "Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia". N Engl J Med. 356 (16): 1620–30. doi:10.1056/NEJMoa071359. PMID 17387131.