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Sponsored by: |
Schering-Plough |
---|---|
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00705081 |
The purpose of this study is to evaluate the safety and tolerability of the 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 |
---|---|
Hypercholesterolemia |
Drug: ezetimibe Drug: statin |
Study Type: | Observational |
Study Design: | Cohort, 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 |
Enrollment: | 608 |
Study Start Date: | March 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
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
Drug: statin
|
2
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
Drug: statin
|
Sampling method: invitation to the physician's patients.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
subjects with hypercholesterolemia
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04276 |
Study First Received: | June 23, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00705081 |
Health Authority: | Indonesia: National Agency of Drug and Food Control |
Metabolic Diseases Hyperlipidemias Ezetimibe Metabolic disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Anticholesteremic Agents Pharmacologic Actions |