Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in co-Administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705081

Purpose

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Ezetimibe

U.S. FDA Resources

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Evaluation of the safety and tolerability of the LDL-C lowering [ Time Frame: 4-6 weeks after the first visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

evaluation of the extent of LDL-C lowering relative to target levels [ Time Frame: 4-6 weeks after the first visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Detailed Description:

Sampling method: invitation to the physician's patients.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

subjects with hypercholesterolemia

Criteria

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

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

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Ezetimibe
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009