search
Back to results

DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia) Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3 History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy Unstable angina within three months prior to inclusion in the study 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)

Sites / Locations

Outcomes

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.

Full Information

First Posted
October 18, 2005
Last Updated
February 5, 2008
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00241488
Brief Title
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

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1362 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary objectives of the study are:
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia) Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3 History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy Unstable angina within three months prior to inclusion in the study 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca China Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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
State/Province
Sarawak
Country
Malaysia
City
Bandar Sunway
State/Province
Selangor
Country
Malaysia
City
Shah Alam
State/Province
Selangor
Country
Malaysia
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
18196620
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.
Results Reference
derived

Learn more about this trial

DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia

We'll reach out to this number within 24 hrs