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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1131-3203 | Other Identifier | UTN | |
| 2012-003049-13 | EudraCT Number |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).
Secondary Objectives:
Total duration of the study per subject (excluding screening) is about 22 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alirocumab + Ezetimibe Placebo | Experimental | Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo |
|
| Alirocumab + Ezetimibe | Experimental | Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe |
|
| Alirocumab + Fenofibrate | Experimental | Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alirocumab | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the effect of alirocumab on LDL-C | Up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the pharmacodynamic profile of alirocumab | Up to 18 weeks | |
| Pharmacokinetics: Assessment of serum concentrations of alirocumab | Up to 18 weeks | |
| Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9) |
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Inclusion criteria :
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 250001 | Rennes | 35000 | France | |||
| Investigational Site Number 250002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27287699 | Result | Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6):e003323. doi: 10.1161/JAHA.116.003323. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
| D000069438 | Ezetimibe |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ezetimibe | Drug | Pharmaceutical form: overencapsulated tablet Route of administration: oral |
|
| Ezetimibe Placebo | Drug | Pharmaceutical form: capsule Route of administration: oral |
|
| Fenofibrate | Drug | Pharmaceutical form: tablet Route of administration: oral |
|
| Up to 18 weeks |
| Rueil-Malmaison |
| 92502 |
| France |
| D009750 |
| Nutritional and Metabolic Diseases |
| D058607 |
| Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |