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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00427960

Enrollment

Registered

2007-01-29

Start date

2006-12-31

Completion date

2008-02-29

Last updated

2010-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia

Keywords

cholesterol, statin, Asian, LDL-cholesterol

Brief 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.

Interventions

BEHAVIORALDietary advice

DRUGrosuvastatin

rosuvastatin 5 mg

DRUGatorvastatin

atorvastatin 10 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)	6 weeks (baseline) and 12 weeks	Calculated as LDL-C at Week 6 - LDL-C at Week 12\] \* 100

Secondary

Measure	Time frame	Description
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	—
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.	6 weeks (baseline) and 12 weeks	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	6 weeks (baseline) and 12 weeks	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)	6 weeks (baseline) and 12 weeks	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	6 weeks (baseline) and 12 weeks	—
The Percentage Change From Baseline (Week 6)in Non-HDL-C	6 weeks (baseline) and 12 weeks	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 General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L	6 weeks (Baseline) and 12 weeks	—
The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)	6 weeks (baseline) and 12 weeks	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	6 weeks (baseline) and 12 weeks	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	6 weeks (baseline) and 12 weeks	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	6 weeks (baseline) and 12 weeks	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	6 weeks (baseline) and 12 weeks	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.	6 weeks (baseline) and 12 weeks	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 (Week 6) in Apolipoprotein-B (ApoB)	6 weeks (baseline) and 12 weeks	Derived according to the following formula: 100\*\[Lipid at week 12 - Lipid at week 6\]/Lipid at week 6

Countries

United Kingdom

Participant flow

Recruitment details

Participants were recruited from 25 primary and secondary care centres in the United Kingdom. The first participant was enrolled on 20th December 2006 and the last participant entered the study on 16th November 2007.

Pre-assignment details

Participants entered an initial 6-week dietary run-in/ wash-out period, after which those with a fasting low density lipoprotein cholesterol (LDL-C) of greater than or equal to 4.00 mmol/L and triglycerides (TG) less than 4.52 mmol/L, were randomised to receive treatment with either rosuvastatin 5 mg plus atorvatstatin , or atorvastatin 10mg

Participants by arm

Arm	Count
Rosuvastatin rosuvastatin 5 mg	30
Atorvastatin atorvastatin 10 mg	25
Total	55

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	0
Overall Study	Other	0	1
Overall Study	Withdrawal by Subject	0	3

Baseline characteristics

Characteristic	Rosuvastatin	Atorvastatin	Total
Age Continuous	50 years STANDARD_DEVIATION 11	53 years STANDARD_DEVIATION 11	51.5 years STANDARD_DEVIATION 11
Sex: Female, Male Female	13 Participants	11 Participants	24.0 Participants
Sex: Female, Male Male	17 Participants	14 Participants	31.0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	4 / —	3 / —
serious Total, serious adverse events	1 / —	0 / —

Outcome results

Primary