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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: June 23, 2008
Last updated: December 2, 2010
Last verified: December 2010

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 Intervention
Drug: ezetimibe
Drug: statin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Number of Participants Reporting Adverse Events [ Time Frame: 4-6 weeks after the first visit ] [ Designated as safety issue: Yes ]
    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.)

  • Intensity of Adverse Events Reported [ Time Frame: 4-6 weeks after the first visit ] [ Designated as safety issue: Yes ]
    Intensity of adverse events reported after co-administration therapy

  • Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy [ Time Frame: 4-6 weeks after the first visit ] [ Designated as safety issue: No ]
    Achievement of LDL-C target levels as determined by physician

Enrollment: 453
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

Sampling method: invitation to the physician's patients.


Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00705081     History of Changes
Other Study ID Numbers: P04276
Study First Received: June 23, 2008
Results First Received: March 26, 2009
Last Updated: December 2, 2010
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014