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DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00241488
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : February 7, 2008
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : June 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Secondary objectives of the study are:
  2. 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.
  3. 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.
  4. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
  2. Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3
  3. History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
  4. Unstable angina within three months prior to inclusion in the study
  5. 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
  6. Known uncontrolled diabetes
  7. Uncontrolled hypertension defined as either resting diastolic blood pressure of > 95mmHg or resting systolic blood pressure of > 200 mmHg
  8. Unexplained serum CK > 3 times ULN (eg not due to recent trauma, intramuscular injections, heavy exercise etc)
  9. Serum creatinine > 220 µmol/L (2.5mg/dL)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00241488

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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
Kuching, Sarawak, Malaysia
Bandar Sunway, Selangor, Malaysia
Shah Alam, Selangor, Malaysia
Kuala Lumpur, Malaysia
Penang, Malaysia
Petaling Jaya, Malaysia
Seberang Perai Utara, Malaysia
Chunghua City, Taiwan
Kaohsiung, Taiwan
Taichung City, Taiwan
Taipei, Taiwan
Tao-Yuan, Taiwan
Bangkok, Thailand
Sponsors and Collaborators
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Study Director: AstraZeneca China Medical Director, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00241488    
Other Study ID Numbers: D3560L00009
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: February 7, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors