To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia

Hyperlipidemias Clinical Trial

Official title:

To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726362
• Other study ID #: NIS-CTW-CRE-2007/1
• Status: Completed
• Phase: N/A
• First received: July 29, 2008
• Last updated: December 2, 2010
• Start date: December 2007
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3270
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperlipidemias

Locations

Country	Name	City	State
Taiwan	Research Site	Changhua
Taiwan	Research Site	Hualien
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Pingtung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Yun-Lin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on LDL-C, HDL-C, TG, TC		3~6 months	No
Secondary	ratio for treatment-to-goal		3~6 months	No
Secondary	drug compliance		3~6 months	No
Secondary	correlation between patient's insight and therapeutic outcome		3~6 months	No