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This study will evaluate the effects of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anacetrapib | Experimental | 100 mg tablet, oral, once daily for 24 weeks |
|
| Placebo | Placebo Comparator | Matching tablet to Anacetrapib 100 mg, oral, once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anacetrapib | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) | Baseline and Week 24 | |
| Percent Change from Baseline in HDL-C | Baseline and Week 24 | |
| Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN) | 24 weeks | |
| Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms | 24 weeks | |
| Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN) | 24 weeks | |
| Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause | 24 weeks | |
| Number of Participants with Significant Increase in Blood Pressure | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in non-HDL-C | Baseline and Week 24 | |
| Percent Change from Baseline in Apolipoprotein B (Apo-B) | Baseline and Week 24 | |
| Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28624096 | Result | Ballantyne CM, Shah S, Sapre A, Ashraf TB, Tobias SC, Sahin T, Ye P, Dong Y, Sheu WH, Kang DH, Ferreira Rossi PR, Moiseeva Y, Briones IR, Johnson-Levonas AO, Mitchel YB. A Multiregional, Randomized Evaluation of the Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients With Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol. Am J Cardiol. 2017 Aug 15;120(4):569-576. doi: 10.1016/j.amjcard.2017.03.255. Epub 2017 Apr 12. |
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| Drug |
|
| Baseline and Week 24 |
| Percent Change from Baseline in Lipoprotein(a) (lp[a]) | Baseline and Week 24 |
| Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C Goal | Baseline and Week 24 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C530884 | anacetrapib |
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