NCT00726362

Brief Summary

The primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of usual clinical practice or captured upon its availability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

8 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

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

1.9 years

First QC Date

July 29, 2008

Last Update Submit

December 2, 2010

Conditions

Keywords

StatinLDL-C

Outcome Measures

Primary Outcomes (1)

  • Changes on LDL-C, HDL-C, TG, TC

    3~6 months

Secondary Outcomes (3)

  • ratio for treatment-to-goal

    3~6 months

  • drug compliance

    3~6 months

  • correlation between patient's insight and therapeutic outcome

    3~6 months

Study Arms (1)

1

patients with hyperlipidemia newly initiating a statin; or switched from current therapy to a statin, or require dosage adjustment for statin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

based on regular practice and judged by physicians, patients with hyperlipidemia who need to start prescribed with a statin; or to switch from current therapy to a statin, or require dosage adjustment for statin

You may qualify if:

  • patients diagnosed with hyperlipidemia
  • Patients who are just starting a statin treatment, who need to switch from current therapy to a statin medication, or who are receiving dosage adjustment of statin as judged by the physicians
  • Patients who are willing to participate in this study and who sign an informed consent form

You may not qualify if:

  • Pregnancy or breast feeding
  • Patient are illiterate or unable to fill the questionnaire for any reason
  • Patients with contraindications to the use of certain statins as needed prescribed by physicians (as per commercially available statins package insert) including the use of rosuvastatin.
  • Any clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Changhua, Taiwan

Location

Research Site

Douliu, Taiwan

Location

Research Site

Hualien City, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

Pingtung City, Taiwan

Location

Research Site

Taichung, Taiwan

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wen-Ter Lai, MD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

December 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations