DyslipidaemiaPhase 3NCT00654602
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
A Phase 3 study testing Rosuvastatin and Maintenance of specific diet in people with Dyslipidaemia, run by AstraZeneca.
Trial summary
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidaemia
- What is being tested?
- Rosuvastatin and Maintenance of specific diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Nov 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Fasting low density lipoprotein level as defined by the protocol.
- Fasting triglyceride level as defined by the protocol.
Who cannot join
- The use of lipid lowering drugs or dietary supplements after Visit 1.
- Active arterial disease eg Unstable angina, or recent arterial surgery.
- Blood lipid levels above the limits defined in the protocol.
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
About this study
Official title: A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.
- Conditions
- Dyslipidaemia
- Being tested
- Rosuvastatin, Maintenance of specific diet
- Keywords
- cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Maintenance of specific dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in low density lipoprotein cholesterol levels
Measured: 12 weeks
Secondary outcomes (3)
Reduction in low density lipoprotein cholesterol levels
Measured: 24 & 48 weeks
Safety: adverse events & abnormal laboratory markers
Measured: 4 weekly until week 12 then 12 weekly thereafter.
Maintenance of lowered low density lipoprotein cholesterol level
Measured: Between week 12-48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startFeb 2002
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Evan Stein, Principal investigator, Metabolic & Athersclerotic research centre, USARussell Esterline, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654602
- Sponsor's protocol ID
- 4522IL/0091
- Other IDs
- D3560C00091
- Status last verified
- May 2009
- First submitted
- 3 Apr 2008
- Last updated
- 28 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.
- ClinicalTrials.gov ID
- NCT00654602
- Acronym / sponsor ID
- 4522IL/0091
- Conditions
- Dyslipidaemia
- Keywords
- cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- Nov 2004 (actual)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fasting low density lipoprotein level as defined by the protocol.
- Fasting triglyceride level as defined by the protocol.
Key exclusion criteria (4 listed)
- The use of lipid lowering drugs or dietary supplements after Visit 1.
- Active arterial disease eg Unstable angina, or recent arterial surgery.
- Blood lipid levels above the limits defined in the protocol.
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Crestor | Drug | – |
| Maintenance of specific diet | Behavioural | – |
Primary outcome
Reduction in low density lipoprotein cholesterol levels
Time frame: 12 weeks
3 secondary outcomes
Reduction in low density lipoprotein cholesterol levels
Time frame: 24 & 48 weeks
Safety: adverse events & abnormal laboratory markers
Time frame: 4 weekly until week 12 then 12 weekly thereafter.
Maintenance of lowered low density lipoprotein cholesterol level
Time frame: Between week 12-48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2009.
Related trials for Dyslipidaemia
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Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
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Truway Diagnostic Tools in Primary Care
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Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): A Study at the San Raffaele Hospital Center for Metabolic Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Evan Stein principal investigator
Metabolic & Athersclerotic research centre, USA
Russell Esterline study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin and Maintenance of specific diet in people with Dyslipidaemia, run by AstraZeneca.
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 4 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: finished, as of the sponsor's last update on 28 May 2009. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in low density lipoprotein cholesterol levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2009.