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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01352897
First received: May 9, 2011
Last updated: May 11, 2011
Last verified: May 2011
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LDL-cholesterol levels [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • HDL-cholesterol levels [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Proportion of patients having raised levels of serum CK or ALT [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MC MD, AstraZeneca Singapore
ClinicalTrials.gov Identifier: NCT01352897     History of Changes
Other Study ID Numbers: NIS-CSG-CRE-2011/1
Study First Received: May 9, 2011
Last Updated: May 11, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by AstraZeneca:
Cholesterol
rosuvastatin
retrospective

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

ClinicalTrials.gov processed this record on October 23, 2014