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

Hypercholesterolaemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352897
• Other study ID #: NIS-CSG-CRE-2011/1
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: May 11, 2011
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary hypercholesterolemia

• Subjects from first rosuvastatin Registry study

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Locations

Country	Name	City	State
Singapore	Research Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who maintain US NCEP ATP III LDL-C target goals after long-term therapy		Up to 8 years	No
Secondary	LDL-cholesterol levels		Up to 8 years	No
Secondary	HDL-cholesterol levels		Up to 8 years	No
Secondary	Proportion of patients having raised levels of serum CK or ALT		Up to 8 years	Yes