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Registry On Efficacy and Safety Of Rosuvastatin, and Atorvastatin and Simvastatin In Hypercholesterolaemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01352897
First Posted: May 12, 2011
Last Update Posted: May 12, 2011
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 objective of this follow-up retrospective study is to evaluate the long term efficacy and safety of rosuvastatin in reducing lipid parameters in clinical practice.

Condition
Hypercholesterolaemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Registry to Collect Data of Efficacy and Safety Between Rosuvastatin, and Atorvastatin and Simvastatin In Subjects With Type IIa and IIb Hypercholesterolaemia Under Real Clinical Settings

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of patients who maintain US NCEP ATP III LDL-C target goals after long-term therapy [ Time Frame: Up to 8 years ]

Secondary Outcome Measures:
  • LDL-cholesterol levels [ Time Frame: Up to 8 years ]
  • HDL-cholesterol levels [ Time Frame: Up to 8 years ]
  • Proportion of patients having raised levels of serum CK or ALT [ Time Frame: Up to 8 years ]

Enrollment: 800
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from primary care and specialist clinics
Criteria

Inclusion Criteria:

  • Primary hypercholesterolemia
  • Subjects from first rosuvastatin Registry study
  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): NCT01352897


Locations
Singapore
Research Site
Singapore, Singapore
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: DR ARTHUR TAN, MBBS ARTHUR TAN HEART CLINIC, GLENEAGLES MEDICAL CENTRE
  More Information

Responsible Party: MC MD, AstraZeneca Singapore
ClinicalTrials.gov Identifier: NCT01352897     History of Changes
Other Study ID Numbers: NIS-CSG-CRE-2011/1
First Submitted: May 9, 2011
First Posted: May 12, 2011
Last Update Posted: May 12, 2011
Last Verified: May 2011

Keywords provided by AstraZeneca:
Cholesterol
rosuvastatin
retrospective

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