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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00726362
First received: July 29, 2008
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

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 ]

Enrollment: 3270
Study Start Date: December 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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

Locations
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, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Wen-Ter Lai, MD Kaohsiung Medical University
  More Information

No publications provided

Responsible Party: William Huang/Medical Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00726362     History of Changes
Other Study ID Numbers: NIS-CTW-CRE-2007/1
Study First Received: July 29, 2008
Last Updated: December 2, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by AstraZeneca:
Statin
LDL-C

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013