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| ID | Type | Description | Link |
|---|---|---|---|
| D3560L00009 | |||
| DISCOVERY-Asia |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Visit 1:
Written informed consent to participate in the trial (Appendix B)
Male or female subjects, age > 18 years
Primary hypercholesterolaemia with CV risk > 20%/10yrs, type 2 diabetes, a history of CHD or other established atherosclerotic disease (definition given in Appendix L).
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.
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:
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)
Newly treated subjects, after a six-weeks dietary counselling, will have fasting LDL-C levels > 3.5 mmol/L (135 mg/dL)
Fasting triglycerides £ 4.52 mmol/L (400 mg/dL)
Switched patients must stop current lipid lowering treatment at randomisation (Visit 2)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca China Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18196620 | Derived | 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. doi: 10.1185/030079907x242809. |
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| 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. |
| Ching Qing |
| China |
| Guangzhou | China |
| Harbin | China |
| Jinan | China |
| Nanjing | China |
| Shanghai | China |
| Shenyang | China |
| Wuhan | China |
| New Territories | Hong Kong |
| Kuching | Sarawak | Malaysia |
| Shah Alam | Selangor | Malaysia |
| Sunway City | Selangor | Malaysia |
| George Town | Malaysia |
| Kuala Lumpur | Malaysia |
| Petaling Jaya | Malaysia |
| Seberang Perai Utara | Malaysia |
| Busan | South Korea |
| Cheonan-si | South Korea |
| Daegu | South Korea |
| Ilsan | South Korea |
| Incheon | South Korea |
| Kwangju | South Korea |
| Pusan | South Korea |
| Pyungchon Kyonggi | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| Wŏnju | South Korea |
| Chunghua City | Taiwan |
| Kaohsiung City | Taiwan |
| Taichung | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| Bangkok | Thailand |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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