Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: April 1, 2008
Last updated: April 4, 2017
Last verified: April 2017
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.
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Number of Participants With Adverse Events and Adverse Reactions [ Time Frame: Throughout 1 year of study ]
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.
| Actual Study Start Date:
||December 1, 2007
| Study Completion Date:
||June 1, 2009
| Primary Completion Date:
||June 1, 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 58235
Simvastatin 20 mg daily
|Ages Eligible for Study:
||20 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
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No Contacts or Locations Provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 1, 2008
|Results First Received:
||May 27, 2010
||April 4, 2017
|Individual Participant Data (IPD) Sharing Statement:
|Plan to Share IPD:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2017
Lipid Metabolism Disorders
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors