HypercholesterolaemiaPhase 4NCT00427960
Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg
A Phase 4 study testing Dietary advice, rosuvastatin and atorvastatin in people with Hypercholesterolaemia, run by AstraZeneca at 9 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- Dietary advice, rosuvastatin and atorvastatin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Dec 2006to Feb 2008
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self described Asian, first or second generation
- Male or female > or = 18 years with primary hypercholesterolaemia.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Research Site
Allerton
Research Site
Birmingham
Research Site
Blackburn
Research Site
Bolton
Research Site
Crawley
Research SIte
Glasgow
Research Site
Newcastle
Research SIte
Sheffield
Research SIte
Slough
About this study
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
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.
- Conditions
- Hypercholesterolaemia
- Being tested
- Dietary advice, rosuvastatin, atorvastatin
- Keywords
- cholesterol, statin, Asian, LDL-cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary adviceBehavioural
rosuvastatinDrug
Also called Crestor
rosuvastatin 5 mg
atorvastatinDrug
atorvastatin 10 mg
| Study group | Role | What they receive |
|---|---|---|
| rosuvastatin | Active comparator | rosuvastatin 5 mg Receives: Behavioral: Dietary advice; Drug: rosuvastatin |
| atorvastatin | Active comparator | atorvastatin 10 mg Receives: Behavioral: Dietary advice; Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)
Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100
Measured: 6 weeks (baseline) and 12 weeks
Secondary outcomes (14)
The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L
Measured: 6 weeks (Baseline) and 12 weeks
The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L
Measured: 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.
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.
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 6 weeks (baseline) and 12 weeks
The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 6 weeks (baseline) and 12 weeks
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
Measured: 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.
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.
Measured: 6 weeks (baseline) and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: Due to inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rhiannon Rowsell, MD, Study director, AstraZenecaShahid Ali, MD, Principal investigator, Bradford PCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427960
- Sponsor's protocol ID
- D3560L00060
- Other IDs
- SHUKRA
- Status last verified
- Nov 2010
- First submitted
- 25 Jan 2007
- Last updated
- 16 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov