DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00241488
First received: October 18, 2005
Last updated: February 5, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Drug: Rosuvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Estimated Enrollment: 1362
Study Start Date: June 2003
Study Completion Date: February 2007
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241488

Locations
China
Beijing, China
Ching Qing, China
Guang Zhou, China
Harbin, China
Ji Nan, China
Nanjing, China
Shanghai, China
Shenyang, China
Wu Han, China
Hong Kong
New Territories, Hong Kong
Korea, Republic of
Busan, Korea, Republic of
Cheonan-si, Korea, Republic of
Daegu, Korea, Republic of
Ilsan, Korea, Republic of
Incheon-Si, Korea, Republic of
Kwangju, Korea, Republic of
Pusan, Korea, Republic of
Pyungchon Kyonggi, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Wonju, Korea, Republic of
Malaysia
Kuching, Sarawak, Malaysia
Bandar Sunway, Selangor, Malaysia
Shah Alam, Selangor, Malaysia
Kuala Lumpur, Malaysia
Penang, Malaysia
Petaling Jaya, Malaysia
Seberang Perai Utara, Malaysia
Taiwan
Chunghua City, Taiwan
Kaohsiung, Taiwan
Taichung City, Taiwan
Taipei, Taiwan
Tao-Yuan, Taiwan
Thailand
Bangkok, Thailand
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca China Medical Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00241488     History of Changes
Other Study ID Numbers: D3560L00009, D3560L00009, DISCOVERY-Asia
Study First Received: October 18, 2005
Last Updated: February 5, 2008
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014