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

Organon and Co453 enrolled

Overview

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.

Sampling method: invitation to the physician's patients.

Study Type

OBSERVATIONAL

Enrollment

453

Conditions

Hypercholesterolemia

Interventions

ezetimibeDRUG

10 mg once daily

statinDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice Exclusion Criteria: * N/A

Outcomes

Primary Outcomes

Number of Participants Reporting Adverse Events

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.)

Time frame: 4-6 weeks after the first visit

Intensity of Adverse Events Reported

Intensity of adverse events reported after co-administration therapy

Time frame: 4-6 weeks after the first visit

Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy

Achievement of LDL-C target levels as determined by physician

Time frame: 4-6 weeks after the first visit

Data from ClinicalTrials.gov

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