Awareness of Chinese National Adult Lipid Treatment Guideline (2007) and Rate of Patients Achieving the Treatment Goal - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00781560

Purpose

This study is designed to survey the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists; To survey the control rate of the patients with dyslipidemia in "real world"; and to evaluate the percentage of hyperlipidemia patients who achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline (2007) following 8-week treatment by Crestor® 5mg or 10mg

Condition
Hyperlipidemia

Drug Information available for: Rosuvastatin Rosuvastatin calcium Lipids

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Cross-Sectional Study to Survey the Awareness of Chinese National Adult Lipid Treatment Guideline (2007) and the Rate of Patients (on Treatment) Achieving the Hyperlipidaemia Treatment Goal With Crestor 5mg to 10mg for 8 Weeks

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists [ Time Frame: 1 time ] [ Designated as safety issue: No ]
the control rate of patients reaching target LDL-C level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the percent change from baselines in TC, TG, HDL-C [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
the percentage of hyperlipidemia patients in different risk categories who achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline (2007) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2400
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009

Groups/Cohorts
1 patients being diagnosed as dyslipidemia but not receiving Crestor®
2 hypercholesterolemia or mixed dyslipidemia and have been initiated treatment with Crestor®

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 who has been diagnosed as hypercholesterolemia and decided by physician to use Crestor® 5mg or 10mg or other regimens (TLC or other lipid-lowering agents)

Criteria

Inclusion Criteria:

Diagnosed as dyslipidemia by doctors
Having lipids test and record within one months
Diagnosed as hypercholesterolemia or mixed dyslipidaemias and has been prescribed Crestor® 5mg or 10mg

Exclusion Criteria:

Unable or unwilling to provide the Inform Consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781560

Contacts

Contact: AstraZeneca China Clinical Study Information

0086 21 5256 4555

tristin.zhao@astrazeneca.com

Locations

China
Research Site
Shanghai, China
Research Site
Beijing, China
China, Henan
Research Site
ZhengZhou, Henan, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shandong
Research Site
Qingdao, Shandong, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
China, Zhejiang
Research Site
Hang Zhou, Zhejiang, China
Research Site
Wenzhou, Zhejiang, China

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Karen Atkin	Astrazeneca China R&D
Principal Investigator:	Zhu Junren	Zhongshan Hospital Fudan University

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Karen Atkin/ VP. China R&D )
Study ID Numbers:	NIS-CCN-CRE-2008/1
Study First Received:	October 28, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00781560
Health Authority:	China: State Food and Drug Administration

Keywords provided by AstraZeneca:

Hyperlipidemia
Chinese National Adult Lipid Treatment Guideline (2007)
Crestor®

Study placed in the following topic categories:

Rosuvastatin
Metabolic Diseases
Hyperlipidemias

Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009