HypercholesterolemiaNCT00396110
Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)
An observational study of Hypercholesterolemia and Coronary Heart Disease, run by AstraZeneca.
Trial summary
In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET) representing daily practice. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Coronary Heart Disease
- How many people
- 3,889 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to not given
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-risk patients with and without evident CHD who had LDL-C > 3.2 mmol/l and were treated at that moment with HMG-CoA-reductase inhibitor apart from rosuvastatin.
- Patients were aged >18 years and <70 years (men) and < 75 years (women).
Who cannot join
- Treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg
- Patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin
About this study
In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET) representing daily practice. Primary end points analysis was the percentage of patients reaching the target of LDL-C < 3.2 mmol/l. Secondary outcomes were the changes of LDL-C, HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.
- Conditions
- Hypercholesterolemia, Coronary Heart Disease
- Keywords
- cholesterol, coronary heart disease, rosuvastatin, LDL-C goal, hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia, Coronary Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 3,889 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ingrid van Geel, MD, Study chair, AstraZenecaIngeborg Vosjan, MD, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396110
- Sponsor's protocol ID
- 25V06
- Other IDs
- TARGET
- Status last verified
- Feb 2003
- First submitted
- 3 Nov 2006
- Last updated
- 6 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)
- ClinicalTrials.gov ID
- NCT00396110
- Acronym / sponsor ID
- 25V06
- Conditions
- Hypercholesterolemia, Coronary Heart Disease
- Keywords
- cholesterol, coronary heart disease, rosuvastatin, LDL-C goal, hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,889 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- First posted
- 6 Nov 2006 (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.
In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET) representing daily practice. Primary end points analysis was the percentage of patients reaching the target of LDL-C < 3.2 mmol/l. Secondary outcomes were the changes of LDL-C, HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- High-risk patients with and without evident CHD who had LDL-C > 3.2 mmol/l and were treated at that moment with HMG-CoA-reductase inhibitor apart from rosuvastatin.
- Patients were aged >18 years and <70 years (men) and < 75 years (women).
Key exclusion criteria (2 listed)
- Treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg
- Patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Nov 2006.
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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.
Ingrid van Geel, MD study chair
AstraZeneca
Ingeborg Vosjan, MD study chair
AstraZeneca
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Coronary Heart Disease, 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 2 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 6 Nov 2006. 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.
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.
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 6 Nov 2006.