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Completed

NCT Number: NCT00871351

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

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.

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Key information

Conditions

Primary Hypercholesterolemia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ezetimibe

Drug

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Other names: SCH 058235

atorvastatin

Drug

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Rosuvastatin

Drug

1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Primary outcomes

  1. Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values

    Time frame: End of Week 4 to Week 16 or discontinuation

    LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).

Secondary outcomes

  1. Percent Change in LDL-C

    Time frame: End of washout period to Week 16 or discontinuation

    LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).

  2. Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values

    Time frame: Week 16 or discontinuation

    LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).

    Target values:

    For participants with history of coronary artery disease: <100 mg/dL;

    for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;

    for participants with 1-2 CV risk factors: <140 mg/dL;

    for participants with no CV risk factors: <160 mg/dL.

  3. Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)

    Time frame: End of Week 4 to Week 16 or discontinuation

    Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.

  4. Percent Change in Total Lipids and Hs-CRP

    Time frame: End of washout to Week 16 or discontinuation

    Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2009
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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