DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia
: 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)
2 other identifiers
interventional
1,362
6 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2003
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFebruary 7, 2008
February 1, 2008
2.5 years
October 18, 2005
February 5, 2008
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Unknown Facility
Beijing, China
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Ching Qing, China
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Guangzhou, China
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Harbin, China
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Jinan, China
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Nanjing, China
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Shanghai, China
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Shenyang, China
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Wuhan, China
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New Territories, Hong Kong
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Kuching, Sarawak, Malaysia
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Shah Alam, Selangor, Malaysia
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Sunway City, Selangor, Malaysia
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George Town, Malaysia
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Kuala Lumpur, Malaysia
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Petaling Jaya, Malaysia
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Seberang Perai Utara, Malaysia
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Busan, South Korea
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Cheonan-si, South Korea
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Daegu, South Korea
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Ilsan, South Korea
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Incheon, South Korea
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Kwangju, South Korea
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Pusan, South Korea
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Pyungchon Kyonggi, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Wŏnju, South Korea
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Chunghua City, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
Unknown Facility
Bangkok, Thailand
Related Publications (1)
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.
PMID: 18196620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca China Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 19, 2005
Study Start
June 1, 2003
Primary Completion
December 1, 2005
Study Completion
February 1, 2007
Last Updated
February 7, 2008
Record last verified: 2008-02