DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Rosuvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca China Medical Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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:
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)
Locations and Contacts
Shanghai, China
nanjing, China
Beijing, China
Harbin, China
Shenyang, China
Guang Zhou, China
Ji Nan, China
Wu Han, China
Ching Qing, China
New Territories, Hong Kong
Seoul, Korea, Republic of
Daegu, Korea, Republic of
Cheonan-si, Korea, Republic of
Busan, Korea, Republic of
Pusan, Korea, Republic of
Suwon, Korea, Republic of
Wonju, Korea, Republic of
Ilsan, Korea, Republic of
Incheon-Si, Korea, Republic of
Kwangju, Korea, Republic of
Pyungchon Kyonggi, Korea, Republic of
Kuala Lumpur, Malaysia
Petaling Jaya, Malaysia
Seberang Perai Utara, Malaysia
Penang, Malaysia
Taipei, Taiwan
Taichung City, Taiwan
Kaohsiung, Taiwan
Tao-Yuan, Taiwan
Chunghua City, Taiwan
Bangkok, Thailand
Kuching, Sarawak, Malaysia
Bandar Sunway, Selangor, Malaysia
Shah Alam, Selangor, Malaysia
Additional Information
Starting date: June 2003
Ending date: February 2007
Last updated: February 5, 2008
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