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

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.

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

Sampling method: invitation to the physician's patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

ezetimibe

Drug

10 mg once daily

Other names: SCH 58235

Statin

Drug

Primary outcomes

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.)
Intensity of Adverse Events Reported

Time frame: 4-6 weeks after the first visit

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

Achievement of LDL-C target levels as determined by physician

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Observational Study Evaluating the LDL-C Lowering Effects of Ezetimibe With a Statin as Prescribed in Daily Routine Practice in an Indonesian Population

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Jun 25, 2008
Registry last updated: Feb 9, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed