NCT00526552

Brief Summary

To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with diabetes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

2 months

First QC Date

September 5, 2007

Last Update Submit

March 29, 2010

Conditions

DyslipidemiaDiabetes

Keywords

dyslipidemiarosuvastatindiabetescholesterolNaturalisticObservational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic Mellitus patients with hypercholesteromia in Korean tertiary care centers

You may qualify if:

  • Hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on clinical grounds and fulfil the following criteria
  • Over 18 years of age
  • Diagnosed with DM based on fasting or post-load glucose data and/or clinical assessment by the clinician

You may not qualify if:

  • Patients already taking other hyperlipidemic agents
  • Patients who do not fulfil the indication criteria for statin therapy
  • Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Seoul, Jongro-gu, South Korea

Location

Research Site

Seoul, Kangnam-gu, South Korea

Location

Research Site

Seoul, Songpa-gu, South Korea

Location

MeSH Terms

Conditions

DyslipidemiasDiabetes Mellitus

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Hyunah Caroline Choi

    AstraZeneca Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 10, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2007

Study Completion

December 1, 2007

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations

KR(3)