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The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvastatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in low density lipoprotein cholesterol after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation | ||
| Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18312764 | Derived | Stein EA, Ballantyne CM, Windler E, Sirnes PA, Sussekov A, Yigit Z, Seper C, Gimpelewicz CR. Efficacy and tolerability of fluvastatin XL 80 mg alone, ezetimibe alone, and the combination of fluvastatin XL 80 mg with ezetimibe in patients with a history of muscle-related side effects with other statins. Am J Cardiol. 2008 Feb 15;101(4):490-6. doi: 10.1016/j.amjcard.2007.09.099. Epub 2007 Dec 20. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077340 | Fluvastatin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Number of patients who reach target LDL after 12 weeks |
| Change from baseline in marker of inflammation after 12 weeks |
| Investigative Centers |
| Germany |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |