DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00241488

Purpose

This clinical trial is being performed to investigate the effect of 12 weeks treatment with rosuvastatin and atorvastatin in bringing subjects to their established EAS LDL-C target goal.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Rosuvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	: An Open-Label, Randomised, Multi-Centre, Phase IIIb/IV, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin and Atorvastatin in Subjects With Type IIa and IIb Hypercholesterolaemia (DISCOVERY)

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy

Secondary Outcome Measures:

Secondary objectives of the study are:
1. To compare the efficacy of rosuvastatin 10 mg with atorvastatin 10mg by assessment of the percentage of subjects who reach EAS TC treatment goals after 12 weeks of therapy.
2. Percentage change in LDL-C, TC, HDL-C and TG from pre-dose (week 0) and 12 weeks which will be performed separately for the switched and the naïve patients.
3. To compare rosuvastatin 10 mg with atorvastatin 10 mg after 12 weeks of treatment with respect to the incidence and severity of adverse events and abnormal laboratory values.

Estimated Enrollment:	1362
Study Start Date:	June 2003
Study Completion Date:	February 2007
Primary Completion Date:	December 2005 (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

Criteria

Inclusion Criteria:

Visit 1:
1. Written informed consent to participate in the trial (Appendix B)
2. Male or female subjects, age > 18 years
3. Primary hypercholesterolaemia with CV risk > 20%/10yrs, type 2 diabetes, a history of CHD or other established atherosclerotic disease (definition given in Appendix L).
4. Subjects may be lipid-lowering therapy-naïve, but have completed 6-weeks dietary counselling before this visit OR Subjects may be treated with the 'start' dose of other lipid lowering therapy, which is ineffective, ie. The subject has not met LDL-C treatment goals.
5. Subjects willing to follow all study procedures including attendance at clinics for scheduled study visits, fasting prior to blood draws and compliance with study treatment regimen
  
  Visit 2:
6. Subjects switched from start dose of a lipid lowering therapy (commonly accepted start dose) will have fasting LDL-C levels > 3.1 mmol (120 mg/dl)
7. Newly treated subjects, after a six-weeks dietary counselling, will have fasting LDL-C levels > 3.5 mmol/L (135 mg/dL)
8. Fasting triglycerides £ 4.52 mmol/L (400 mg/dL)
9. Switched patients must stop current lipid lowering treatment at randomisation (Visit 2)

Exclusion Criteria:

Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3
History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
Unstable angina within three months prior to inclusion in the study
Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT ³ 1.5 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study
Known uncontrolled diabetes
Uncontrolled hypertension defined as either resting diastolic blood pressure of > 95mmHg or resting systolic blood pressure of > 200 mmHg
Unexplained serum CK > 3 times ULN (eg not due to recent trauma, intramuscular injections, heavy exercise etc)
Serum creatinine > 220 µmol/L (2.5mg/dL)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241488

Locations

China

Beijing, China

Ching Qing, China

Guang Zhou, China

Harbin, China

Ji Nan, China

Nanjing, China

Shanghai, China

Shenyang, China

Wu Han, China
Hong Kong

New Territories, Hong Kong
Korea, Republic of

Busan, Korea, Republic of

Cheonan-si, Korea, Republic of

Daegu, Korea, Republic of

Ilsan, Korea, Republic of

Incheon-Si, Korea, Republic of

Kwangju, Korea, Republic of

Pusan, Korea, Republic of

Pyungchon Kyonggi, Korea, Republic of

Seoul, Korea, Republic of

Suwon, Korea, Republic of

Wonju, Korea, Republic of
Malaysia

Kuching, Sarawak, Malaysia

Bandar Sunway, Selangor, Malaysia

Shah Alam, Selangor, Malaysia

Kuala Lumpur, Malaysia

Penang, Malaysia

Petaling Jaya, Malaysia

Seberang Perai Utara, Malaysia
Taiwan

Chunghua City, Taiwan

Kaohsiung, Taiwan

Taichung City, Taiwan

Taipei, Taiwan

Tao-Yuan, Taiwan
Thailand

Bangkok, Thailand

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca China Medical Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zhu JR, Tomlinson B, Ro YM, Sim KH, Lee YT, Sriratanasathavorn C. A randomised study comparing the efficacy and safety of rosuvastatin with atorvastatin for achieving lipid goals in clinical practice in Asian patients at high risk of cardiovascular disease (DISCOVERY-Asia study). Curr Med Res Opin. 2007 Dec;23(12):3055-68.

ClinicalTrials.gov Identifier:	NCT00241488 History of Changes
Other Study ID Numbers:	D3560L00009, D3560L00009, DISCOVERY-Asia
Study First Received:	October 18, 2005
Last Updated:	February 5, 2008
Health Authority:	China: Ministry of Health

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
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