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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in United Kingdom

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.

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.

Study groups in NCT00427960
Study groupRoleWhat they receive
rosuvastatinActive comparatorrosuvastatin 5 mg
Receives: Behavioral: Dietary advice; Drug: rosuvastatin
atorvastatinActive comparatoratorvastatin 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted29 Jan 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Why it stopped: Due to inadequate recruitment

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dietary advice, rosuvastatin and atorvastatin in people with Hypercholesterolaemia, run by AstraZeneca at 9 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C) (time frame: 6 weeks (baseline) and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00427960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2010.

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