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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00726362
First Posted: July 31, 2008
Last Update Posted: December 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Changes on LDL-C, HDL-C, TG, TC [ Time Frame: 3~6 months ]

Secondary Outcome Measures:
  • ratio for treatment-to-goal [ Time Frame: 3~6 months ]
  • drug compliance [ Time Frame: 3~6 months ]
  • correlation between patient's insight and therapeutic outcome [ Time Frame: 3~6 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: William Huang/Medical Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00726362     History of Changes
Other Study ID Numbers: NIS-CTW-CRE-2007/1
First Submitted: July 29, 2008
First Posted: July 31, 2008
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Statin
LDL-C

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