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Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00705081
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : August 3, 2009
Last Update Posted : July 3, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. In addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.

Condition or disease Intervention/treatment
Hypercholesterolemia Drug: ezetimibe Drug: statin

Detailed Description:
Sampling method: invitation to the physician's patients.

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Study Type : Observational
Actual Enrollment : 453 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Evaluating the LDL-C Lowering Effects of Ezetimibe With a Statin as Prescribed in Daily Routine Practice in an Indonesian Population
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Group/Cohort Intervention/treatment
Not previously treated
subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
Drug: ezetimibe
10 mg once daily
Other Name: SCH 58235

Drug: statin
Previously treated with statin
subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
Drug: ezetimibe
10 mg once daily
Other Name: SCH 58235

Drug: statin

Primary Outcome Measures :
  1. Number of Participants Reporting Adverse Events [ Time Frame: 4-6 weeks after the first visit ]
    Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)

  2. Intensity of Adverse Events Reported [ Time Frame: 4-6 weeks after the first visit ]
    Intensity of adverse events reported after co-administration therapy

  3. Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy [ Time Frame: 4-6 weeks after the first visit ]
    Achievement of LDL-C target levels as determined by physician

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects with hypercholesterolemia

Inclusion Criteria:

  • All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice

Exclusion Criteria:

  • N/A
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00705081    
Other Study ID Numbers: P04276
First Posted: June 25, 2008    Key Record Dates
Results First Posted: August 3, 2009
Last Update Posted: July 3, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents