Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
This study has been terminated.
(Due to inadequate recruitment)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00427960
First received: January 25, 2007
Last updated: November 30, 2010
Last verified: November 2010
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Purpose
The purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian patients in the UK.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolaemia |
Behavioral: Dietary advice Drug: rosuvastatin Drug: atorvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase IV, 6-week, Randomised, Double-blind, Multicentre, Parallel Group, Comparative Study to Evaluate the Efficacy of Rosuvastatin 5mg and Atorvastatin 10mg in UK Asian Subjects With Primary Hypercholesterolaemia |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C) [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100
Secondary Outcome Measures:
- The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L [ Time Frame: 6 weeks (Baseline) and 12 weeks ] [ Designated as safety issue: No ]
- The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
- The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category. [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
Risk categories are:
Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L
Patients are defined as symptomatic if they meet at least 1 of the following criteria:
History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg
Total risk is derived from age, sex, TC, systolic BP and smoking status.
- The Percentage Change From Baseline(week6) in TC [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
- The Percentage Change From Baseline (Week 6)in Non-HDL-C [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB) [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1) [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6
- The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category. [ Time Frame: 6 weeks (baseline) and 12 weeks ] [ Designated as safety issue: No ]
Risk categories are:
Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L
Patients are defined as symptomatic if they meet at least 1 of the following criteria:
History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg
Total risk is derived from age, sex, TC, systolic BP and smoking status.
| Enrollment: | 55 |
| Study Start Date: | December 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: rosuvastatin
rosuvastatin 5 mg
|
Behavioral: Dietary advice
Drug: rosuvastatin
rosuvastatin 5 mg
Other Name: Crestor
|
|
Active Comparator: atorvastatin
atorvastatin 10 mg
|
Behavioral: Dietary advice
Drug: atorvastatin
atorvastatin 10 mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Self described Asian, first or second generation
- Male or female > or = 18 years with primary hypercholesterolaemia.
Exclusion Criteria:
- Use of cholesterol lowering drugs from visit 1
- Homozygous familial hypercholesterolaemia
- Active arterial disease within 3 months of study entry
- Poorly controlled diabetes
- Uncontrolled hypothyroidism
- Active liver disease
- History of alcoh/drug abuse.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427960
Locations
| United Kingdom | |
| Research Site | |
| Allerton, United Kingdom | |
| Research Site | |
| Birmingham, United Kingdom | |
| Research Site | |
| Blackburn, United Kingdom | |
| Research Site | |
| Bolton, United Kingdom | |
| Research Site | |
| Crawley, United Kingdom | |
| Research SIte | |
| Glasgow, United Kingdom | |
| Research Site | |
| Newcastle, United Kingdom | |
| Research SIte | |
| Sheffield, United Kingdom | |
| Research SIte | |
| Slough, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Rhiannon Rowsell, MD | AstraZeneca |
| Principal Investigator: | Shahid Ali, MD | Bradford PCT |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00427960 History of Changes |
| Other Study ID Numbers: | D3560L00060, SHUKRA |
| Study First Received: | January 25, 2007 |
| Results First Received: | March 25, 2009 |
| Last Updated: | November 30, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
cholesterol statin Asian LDL-cholesterol |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin 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 May 16, 2013