DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia

NCT ID: NCT00241488

Last Updated: 2008-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-02-28

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Rosuvastatin

Intervention Type: DRUG

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)

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)

Exclusion Criteria

1. Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca China Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Beijing, , China

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 District, , Taiwan

Bangkok, , Thailand

Countries

China; Hong Kong; Malaysia; South Korea; Taiwan; Thailand

References

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.

Reference Type: DERIVED

PMID: 18196620 (View on PubMed)

Other Identifiers

D3560L00009

Identifier Type: -

Identifier Source: secondary_id

DISCOVERY-Asia

Identifier Type: -

Identifier Source: secondary_id

D3560L00009

Identifier Type: -

Identifier Source: org_study_id