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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00931320

First received: June 30, 2009

Last updated: October 23, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2009

Last Updated Date

October 23, 2009

Start Date ^ICMJE

July 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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. ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00931320 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Dyslipidemias

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

3000 patients

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

3000

Completion Date

September 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00931320

Other Study ID Numbers ^ICMJE

NIS-CKR-DUM-2009/3

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Hyunah Caroline, Choi / CV TA Physician, AstraZeneca Pharmaceuticals

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Hyunah Caroline Choi

AstraZeneca Korea

PRS Account

AstraZeneca

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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