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To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia
This study is currently recruiting participants.
Verified by AstraZeneca, July 2008
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00726362
  Purpose

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.


Condition
Hyperlipidemias

MedlinePlus related topics: Statins
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Changes on LDL-C, HDL-C, TG, TC [ Time Frame: 3~6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ratio for treatment-to-goal [ Time Frame: 3~6 months ] [ Designated as safety issue: No ]
  • drug compliance [ Time Frame: 3~6 months ] [ Designated as safety issue: No ]
  • correlation between patient's insight and therapeutic outcome [ Time Frame: 3~6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 3300
Study Start Date: September 2007
Estimated Study Completion Date: October 2009
Groups/Cohorts
1
patients with hyperlipidemia newly initiating a statin; or switched from current therapy to a statin, or require dosage adjustment for statin

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726362

Contacts
Contact: AstraZeneca Taiwan Clinical Study Information +886-2-2378-2390 jade.lien@astrazeneca.com

Locations
Taiwan
Research Site Recruiting
Changhua, Taiwan
Research Site Recruiting
Hualien, Taiwan
Research Site Recruiting
Kaohsiung, Taiwan
Research Site Recruiting
Pingtung, Taiwan
Research Site Recruiting
Yun-Lin, Taiwan
Research Site Recruiting
Tainan, Taiwan
Research Site Recruiting
Taipei, Taiwan
Research Site Recruiting
Taichung, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Wen-Ter Lai, MD Kaohsiung Medical University
  More Information

Responsible Party: AstraZeneca Pharmaceuticals ( William Huang/Medical Director )
Study ID Numbers: NIS-CTW-CRE-2007/1
Study First Received: July 29, 2008
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00726362  
Health Authority: Taiwan: Institutional Review Board

Keywords provided by AstraZeneca:
Statin
LDL-C

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009