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

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Organon

Status and phase

Completed
Phase 4

Conditions

Hypercholesterolemia

Treatments

Drug: ezetimibe (+) simvastatin
Drug: atorvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00166504
0653A-092
MK0653A-092
2005_070

Details and patient eligibility

About

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.

Enrollment

203 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of hypercholesterolemia
  • LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

203 participants in 2 patient groups

Vytorin
Experimental group
Description:
Ezetimibe 10 mg/Simvastatin 20 mg
Treatment:
Drug: ezetimibe (+) simvastatin
Atorvastatin
Active Comparator group
Description:
Atorvastatin 10 mg
Treatment:
Drug: atorvastatin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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