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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2006-005469-20 |
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The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | oral administration 5 mg breakfast timing |
|
| 2 | Experimental | oral administration 25 mg breakfast timing |
|
| 3 | Experimental | oral administration 50 mg breakfast timing |
|
| 4 | Experimental | oral administration 100 mg breakfast timing |
|
| 5 | Experimental | oral administration 25 mg dinner timing |
|
| 6 | Placebo Comparator | oral administration |
|
| 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVE5530 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in LDL-C from baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from in LDL-C levels | 4 weeks | |
| Percent change in other lipids and lipoprotein fractions from baseline | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Santiago | Chile | ||||
| Sanofi-Aventis Administrative Office |
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| Label | URL |
|---|---|
| Related Info | View source |
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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 |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Active Comparator |
oral administration 10mg breakfast timing |
|
| Drug |
|
| ezetimibe | Drug |
|
| Budapest |
| Hungary |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Seoul | South Korea |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| D009750 |
| Nutritional and Metabolic Diseases |