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

Purpose

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
Hypercholesterolemia	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:

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Ezetimibe

U.S. FDA Resources

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.

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

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:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ezetimibe
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013