Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg

Hypercholesterolaemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00427960
• Other study ID #: D3560L00060
• Secondary ID: SHUKRA
• Status: Terminated
• Phase: Phase 4
• First received: January 25, 2007
• Last updated: November 30, 2010
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Intervention

Behavioral:
• Dietary advice

Drug:
• rosuvastatin
rosuvastatin 5 mg
• atorvastatin
atorvastatin 10 mg

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)	Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L		6 weeks (Baseline) and 12 weeks	No
Secondary	The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L		6 weeks (baseline) and 12 weeks	No
Secondary	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.	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.	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline(week6) in TC	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L		6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline (Week 6)in Non-HDL-C	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio	Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6	6 weeks (baseline) and 12 weeks	No
Secondary	The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.	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.	6 weeks (baseline) and 12 weeks	No