Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

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Organon

Status and phase

Completed
Phase 4

Conditions

Primary Hypercholesterolemia

Treatments

Drug: Rosuvastatin
Drug: Atorvastatin
Drug: Ezetimibe

Study type

Interventional

Funder types

Industry

Identifiers

NCT00871351
P06027

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Enrollment

125 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C <160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C <140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C <120 mg/dL; and for participants with history of coronary artery disease - LDL-C <100 mg/dL.
  • outpatient men or women, age 20 years and older

Exclusion criteria

  • fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.
  • homozygous familial hypercholesterolemia.
  • creatine phosphokinase (CPK) >2 times the upper limit of normal (X ULN) at start of washout or treatment period.
  • glycosylated hemoglobin (HbA1c) >=8% at start of washout or treatment period.
  • severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X ULN at start of washout or treatment period.
  • hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.
  • pregnant or lactating
  • discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.)
  • cyclosporine treatment
  • hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis.
  • hyperlipidemia associated with drug administration that causes adverse serum lipid effects.
  • participation in a clinical study within 4 weeks of washout
  • cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

125 participants in 3 patient groups

Ezetimibe + Atorvastatin
Experimental group
Description:
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Treatment:
Drug: Ezetimibe
Drug: Atorvastatin
Atorvastatin
Active Comparator group
Description:
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Treatment:
Drug: Atorvastatin
Rosuvastatin
Active Comparator group
Description:
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Treatment:
Drug: Rosuvastatin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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