Clinical trial NCT00241488: DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 1362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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:
measure: Secondary objectives of the study are:
measure: 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.
measure: 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.
measure: 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.
Other outcomes:
Locations:
city: Beijing
country: China
city: Ching Qing
country: China
city: Guang Zhou
country: China
city: Harbin
country: China
city: Ji Nan
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Wu Han
country: China
city: New Territories
country: Hong Kong
city: Busan
country: Korea, Republic of
city: Cheonan-si
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Ilsan
country: Korea, Republic of
city: Incheon-Si
country: Korea, Republic of
city: Kwangju
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Pyungchon Kyonggi
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
city: Kuching
country: Malaysia
state: Sarawak
city: Bandar Sunway
country: Malaysia
state: Selangor
city: Shah Alam
country: Malaysia
state: Selangor
city: Kuala Lumpur
country: Malaysia
city: Penang
country: Malaysia
city: Petaling Jaya
country: Malaysia
city: Seberang Perai Utara
country: Malaysia
city: Chunghua City
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung City
country: Taiwan
city: Taipei
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Bangkok
country: Thailand
Study officials:
affiliation: AstraZeneca
name: AstraZeneca China Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.