Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients (RACHEL)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00931320
First received: June 30, 2009
Last updated: October 23, 2009
Last verified: October 2009
| Tracking Information | |||||
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| 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. ] [ Designated as safety issue: No ] | ||||
| 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. ] [ Designated as safety issue: No ] | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| 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 . |
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| Condition ICMJE | Dyslipidemias | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 3000 patients
Who have at least made 1 visit to the outpatient clinic within previous 6 months . |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 3000 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00931320 | ||||
| Other Study ID Numbers ICMJE | NIS-CKR-DUM-2009/3 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hyunah Caroline, Choi / CV TA Physician, AstraZeneca Pharmaceuticals | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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