A Phase 3 interventional study of Ezetimibe and Atorvastatin in High Cholesterol and Coronary Artery Disease, sponsored by University of California, San Diego. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-21.
Sponsored by University of California, San Diego · Phase 3, Interventional, and Treatment
Response to statin therapy for elevated low density lipoprotein is variable and may be influenced by cholesterol absorption. This study will evaluate whether combination therapy with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less than 25% LDL reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin 20 mg daily).
Specific Aim 1 To identify a patient population seen in the University of California, San Diego general internal medicine and cardiology subspecialty clinics as well as referrals from community physicians who are hyporesponsive to statin therapy (defined as an initial LDL reduction of \<25% in response to 10mg of atorvastatin or 20mg of simvastatin- expected mean reduction is 35% -37% for starting dose simvastatin and atorvastatin).
Specific Aim 2 To test the hypothesis, with a prospective study, that a hyporesponse to statin therapy may be related to increased cholesterol absorption, and that this hyporesponse may be overcome by the addition of ezetimibe, a specific cholesterol absorption inhibitor.
Specific Aim 3 To evaluate whether patients with less than 25% LDL reduction on 10 mg of atorvastatin (or 20 mg of simvastatin) would achieve significantly greater LDL reduction with combination therapy (atorvastatin/ezetimibe) than with statin dose titration (using atorvastatin).
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 2 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Atorvastatin
Drug: Ezetimibe · Drug: Atorvastatin
10 mg
Also known as: Zetia, Lipitor
Visit 1: (atorvastatin open label challenge): Those who complete the initial screening and washout period will receive open label atorvastatin 10 mg daily for 6 weeks to verify compliance and confirm hyporesponse to statin therapy. Visit 2: After 6 weeks of therapy repeat baseline fasting cholesterol. Those with LDL-c reduction of 25% or less will be able to proceed to next phase. Patients with greater than 25% LDL-C reduction will be excluded. We expect to randomize 80 patients Visit 2a: Dispensing of first randomized drug allocation- all patients receive open label atorvastatin 10 mg with additional ezetimibe 10 mg or matching placebo. No blood test during this visit. Visit 3, 4, 5: Dose titration to atorvastatin to 20 mg, 40 mg, 80 mg, respectively, after fasting blood test Blood collected in visits 3, 4, and 5 will be stored for additional tests regarding cholesterol metabolism and inflammation. Visit 6: Final cholesterol panel and conclusion of study period
LDL-C Reduction
Study was not analyzed as only 2 subjects were enrolled and the study was terminated due to lack of enrollment.
Time frame: 6 weeks
LDL-C Reduction as Well as Changes in TG, HDL, and Non-HDL Cholesterol.
Time frame: 24 weeks
| Milestone | All Study Participants |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
Study was not analyzed as only 2 subjects were enrolled and the study was terminated due to lack of enrollment.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
Study was not analyzed as only 2 subjects were enrolled and the study was terminated due to lack of enrollment.
| Age, Categorical | All Study Participants |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Sex: Female, Male | All Study Participants |
|---|---|
| Female | — |
| Male | — |
This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego