Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients (RACHEL)

October 23, 2009 updated by: AstraZeneca

An observational, non-interventional, multi-centre study to provide further information on the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.

Study Overview

Status

Completed

Conditions

Dyslipidemias

Study Type

Observational

Enrollment (Anticipated)

3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Who have at least made 1 visit to the outpatient clinic within previous 6 months .

Description

Inclusion Criteria:

Subjects who are taking lipid-lowering medication after diagnosed as dyslipidaemia
Subjects who have at least made 1 visit to the outpatient clinic within previous 6 months
Subjects who have records of both LDL-C and HDL-C before & after statin treatment (at least four weeks after statin taking)

Exclusion Criteria:

Subjects who are unwilling or unable to provide their examination and lab result of medical chart.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Retrospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
3000 patients Who have at least made 1 visit to the outpatient clinic within previous 6 months .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate current LDL/HDL ratio in Korean patients (between baseline & after treatment) Time Frame: After Treatment : at least 4 weeks before statin taking /Baseline : no limitation.	After Treatment : at least 4 weeks before statin taking /Baseline : no limitation.

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate difference of LDL/HDL ratio among different statins & dosages (between baseline & after treatment) Time Frame: After Treatment : at least 4 weeks before statin taking / Baseline : no limitation.	After Treatment : at least 4 weeks before statin taking / Baseline : no limitation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Hyunah Caroline Choi, AstraZeneca Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria