RADIANCE 2
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RADIANCE 2 On the Web |
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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 Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia
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 mixed hyperlipidemia.
Sponsor
Pfizer
Timeline
| Timeline | |
| Start Date | November 2003 |
| End Date | December 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 NCT00134238.
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 | Mixed hyperlipidemia |
| Intervention | Drug: torcetrapib/atorvastatin Drug: atorvastatin |
| Population Size | 755 |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00134238.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of mixed hyperlipidemia
- 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 measured by carotid ultrasound
Secondary Outcomes
Changes in levels of lipids and other biomarkers
Publications
Conclusion
There is no clinical benefit with the administration of torcetrapib. Torcetrapib did not lead to a decrease in the thickness of the intima and media of carotid segments. Torcetrapib led to an increase in HDL and decrement in LDL; however, these findings were accompanied by an increase in systolic blood pressure.[1]
References
- ↑ Bots ML, Visseren FL, Evans GW, Riley WA, Revkin JH, Tegeler CH; et al. (2007). "Torcetrapib and carotid intima-media thickness in mixed dyslipidaemia (RADIANCE 2 study): a randomised, double-blind trial". Lancet. 370 (9582): 153–60. doi:10.1016/S0140-6736(07)61088-5. PMID 17630038.