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| ID | Type | Description | Link |
|---|---|---|---|
| P01030 | Other Identifier | Schering-Plough Protocol Number | |
| MK-0653-018 | Other Identifier | Merck Protocol Number |
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The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 80 mg | Experimental | 80 mg atorvastatin taken orally, once daily for 12 weeks |
|
| Ezetimibe + Atorvastatin 40 mg | Experimental | 10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks |
|
| Ezetimibe + Atorvastatin 80 mg | Experimental | 10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks |
|
| Simvastatin 80 mg | Experimental | 80 mg simvastatin taken orally, once daily for 12 weeks |
|
| Ezetimibe + Simvastatin 40 mg | Experimental | 10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks |
|
| Ezetimibe + Simvastatin 80 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Tablets taken orally once daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly | Baseline and Up to Week 12 | |
| Percentage of participants with an Adverse Event (AE) | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in calculated LDL-C | Baseline and Up to Week 12 | |
| Percent change from baseline in Total Cholesterol (TC) | Baseline and Up to Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12034651 | Result | Gagne C, Gaudet D, Bruckert E; Ezetimibe Study Group. Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia. Circulation. 2002 May 28;105(21):2469-75. doi: 10.1161/01.cir.0000018744.58460.62. |
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| Experimental |
10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks |
|
| Simvastatin | Drug | Tablets taken orally once daily in the morning or evening |
|
| Ezetimibe | Drug | Tablet taken orally once daily in the morning or evening |
|
| Placebo for Ezetimibe | Drug | Tablets taken orally once daily in the morning or evening |
|
| Percent change from baseline in Triglycerides (TG) |
| Baseline and Up to Week 12 |
| Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C) | Baseline and Up to Week 12 |
| Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C) | Baseline and Up to Week 12 |
| Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C) | Baseline and Up to Week 12 |
| Percent change from baseline in Apolipoprotein A-I (Apo A-I) | Baseline and Up to Week 12 |
| Percent change from baseline in Apolipoprotein B (Apo B) | Baseline and Up to Week 12 |
| Percent change from baseline in Lipoprotein(a) [Lp(a)] | Baseline and Up to Week 12 |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D019821 | Simvastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |
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