Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label, Long-term Study of Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors|
- Number of Participants With Adverse Events and Adverse Reactions [ Time Frame: Throughout 1 year of study ] [ Designated as safety issue: Yes ]
An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.
That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.
Any adverse event that was treatment-related was considered an adverse reaction.
|Study Start Date:||December 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Ezetimibe + Simvastatin
Ezetimibe 10 mg + Simvastatin 20 mg
Ezetimibe 10 mg once daily
Other Name: SCH 58235Drug: Simvastatin
Simvastatin 20 mg daily
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