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Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia

Intervention: ezetimibe (+) simvastatin (Drug); atorvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

Clinical Details

Official title: A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: LDL-C Lowering Efficacy

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of hypercholesterolemia

- LDL-C >/= 130 mg/dL but

- National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III

guideline Exclusion Criteria:

- Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase)

inhibitors or Ezetimibe

Locations and Contacts

Additional Information

Starting date: October 2005
Last updated: January 14, 2015

Page last updated: August 23, 2015

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