Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00683618

Purpose

This trial is to compare the efficacy,safety and tolerability of rosuvastatin with atorvastatin by assessing the change fof LDL-C in patients with hypercholesterolemia and history of coronary heart disease or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: rosuvastatin Drug: Atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomised, Double-blind Trial to Compare the Efficacy of Rosuvastatin 5 and 10 mg to Atorvastatin 10 mg in the Treatment of High Risk Patients With Hypercholesterolemia Followed by an Open Label Treatment Period With Rosuvastatin Up-titrated to the Maximum Dose of 20 mg

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

low-density lipoprotein cholesterol (LDL-C) [ Time Frame: -4Weeks, -1 Week, 0 Week, 6 Weeks, 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

high-density lipoprotein cholesterol (HDL-C),total cholesterol (TC), triglycerides (TG) [ Time Frame: -4Weeks, -1 Week, 0 Week, 6 Weeks, 12 Weeks ] [ Designated as safety issue: No ]
Apolipoprotein B (ApoB), Apolipoprotein A-I (ApoA-I) [ Time Frame: 0 Week, 6 Weeks, 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	438
Study Start Date:	May 2008
Study Completion Date:	July 2009

Arms	Assigned Interventions
Experimental: 1 rosuvastatin 5mg qd	Drug: rosuvastatin Capsule/Tablet, oral, qd, 6 or 12 weeks Other Name: Crestor
Experimental: 2 rosuvastatin 10mg qd	Drug: rosuvastatin Capsule/Tablet, oral, qd, 6 or 12 weeks Other Name: Crestor
Active Comparator: 3 atorvastatin 10mg qd	Drug: Atorvastatin Capsule/Tablet, 10mg, oral, qd, 6 weeks Other Name: Lipitor

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

treated for or diagnosed hypercholesterolemia or have had a high risk with hypercholesterolemia
LDL-C between 3.36mmol/L and 6.5 mmol/L if not treated with statin or between 2.6mmol/L and 4.14 mmol/L
Fasting triglyceride less than 4.52mmol/L

Exclusion Criteria:

History of statin induced myopathy
unstable or uncontrolled cardiovascular diseases
familial dysbetalipoproteinemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683618

Locations

China, Hubei
Research Site
Wuhan, Hubei, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China
Research Site
Beijing, China
Research Site
Shanghai, China
Research Site
Tianjin, China

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Marie Eckerd	AZ Pharmaceuticals - US
Principal Investigator:	Zhao Shuiping	2nd hospital of Xiangya medical university

More Information

No publications provided

Responsible Party:	Marco Avila, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00683618 History of Changes
Other Study ID Numbers:	D356FC00007
Study First Received:	May 21, 2008
Last Updated:	December 1, 2009
Health Authority:	China: Ethics Committee; China: State Food and Drug Administration

Keywords provided by AstraZeneca:

HMG-CoA
LDL-C
CHD

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012