RADIANCE 1: Difference between revisions
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==Official Title== | ==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== | ==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== | ==Sponsor== | ||
Pfizer | |||
==Timeline== | ==Timeline== | ||
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| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Timeline''' | ||
|- | |- | ||
| Style="width:30%"| '''Start Date'''||Style="width:70%"| | | Style="width:30%"| '''Start Date'''||Style="width:70%"|December 2003 | ||
|- | |- | ||
| '''End Date'''|| | | '''End Date'''||November 2006 | ||
|- | |- | ||
| '''Status'''|| | | '''Status'''||Terminated on December 2, 2006 due to safety findings | ||
|- | |- | ||
|} | |} | ||
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Description''' | ||
|- | |- | ||
| Style="width:30%"|'''Study Type'''|| Style="width:70%"| | | Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional | ||
|- | |- | ||
| '''Study Phase''' || | | '''Study Phase''' ||Phase 3 | ||
|- | |- | ||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Design''' | ||
|- | |- | ||
| '''Allocation'''|| | | '''Allocation'''||Randomized | ||
|- | |- | ||
| '''Endpoint'''|| | | '''Endpoint'''||Safety/Efficacy Study | ||
|- | |- | ||
| '''Interventional Model'''|| | | '''Interventional Model'''|| Parallel Assignment | ||
|- | |- | ||
| '''Masking'''|| | | '''Masking'''||Double-Blind | ||
|- | |- | ||
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | | Colspan="2" style="background:Gainsboro" align="center"|'''Study Details''' | ||
|- | |- | ||
| '''Primary Purpose'''|| | | '''Primary Purpose'''||Treatment | ||
|- | |- | ||
| '''Condition'''|| | | '''Condition'''||[[Hypercholesterolemia]], [[familial hyperlipidemia]] | ||
|- | |- | ||
| '''Intervention'''|| | | '''Intervention'''||Drug: [[torcetrapib]]/[[atorvastatin]] <br> Drug: [[atorvastatin]] | ||
|- | |- | ||
| '''Study Arms'''|| | | '''Study Arms'''|| | ||
|- | |- | ||
| '''Population Size'''|| | | '''Population Size'''||800 subjects | ||
|- | |- | ||
|} | |} | ||
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==Outcomes== | ==Outcomes== | ||
===Primary Outcomes=== | ===Primary Outcomes=== | ||
* Change in [[intima media]] thickness as measures by carotid ultrasound | |||
===Secondary Outcomes=== | |||
* Changes in levels of [[lipid]]s and other biomarkers | |||
==Publications== | ==Publications== | ||
Revision as of 15:29, 18 August 2014
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High Density Lipoprotein Microchapters |
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Diagnosis |
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Treatment |
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Clinical Trials |
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Case Studies |
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RADIANCE 1 On the Web |
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American Roentgen Ray Society Images of RADIANCE 1 |
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 |
| Study Arms | |
| 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
Exclusion Criteria
Outcomes
Primary Outcomes
- Change in intima media thickness as measures by carotid ultrasound
Secondary Outcomes
- Changes in levels of lipids and other biomarkers
Publications
Results
Conclusion
Pending