HypercholesterolemiaCHALLENGENCT00574782
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
An observational study of Hypercholesterolemia and Coronary Heart Disease, run by AstraZeneca.
Trial summary
In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA), transient ischemic attack (TIA) or diabetes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Coronary Heart Disease, Peripheral Vascular Disease
- How many people
- 2,660 participants
- Where
- No sites listed yet
- Study dates
- Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for the study were high-risk patients with a documented history of CHD, PVD, cerebrovascular atherosclerotic disease, DM II or DM I with microalbuminuria. LDL-C had to be > 2.5 mmol/l and the patient did not use any cholesterol lowering medication during the last 3 months preceding inclusion. The specialist made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca
Who cannot join
- Exclusion criteria included patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases), patients with familial dyslipideamia like familial hypercholesterolaemia and familial combined hyperlipid
About this study
In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA), transient ischemic attack (TIA) or diabetes (DM), on low-density lipoprotein cholesterol (LDL-C) goal achievement. Also proportional changes in LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG) and the ratio TC/HDL-C were studied.
- Keywords
- cholesterol, coronary heart disease, rosuvastatin, LDL-C goal, hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia, Coronary Disease, Peripheral Vascular Diseases, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startSep 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
- Time perspective
- Prospective
- Enrolment
- 2,660 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ingrid van Geel, Study chair, CVIngeborg Vosjan, Study chair, CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574782
- Sponsor's protocol ID
- NL950057
- Acronym
- CHALLENGE
- Status last verified
- Dec 2007
- First submitted
- 12 Dec 2007
- Last updated
- 17 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
- ClinicalTrials.gov ID
- NCT00574782
- Acronym / sponsor ID
- CHALLENGE / NL950057
- Keywords
- cholesterol, coronary heart disease, rosuvastatin, LDL-C goal, hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,660 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- First posted
- 17 Dec 2007 (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 an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA), transient ischemic attack (TIA) or diabetes (DM), on low-density lipoprotein cholesterol (LDL-C) goal achievement. Also proportional changes in LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG) and the ratio TC/HDL-C were studied.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for the study were high-risk patients with a documented history of CHD, PVD, cerebrovascular atherosclerotic disease, DM II or DM I with microalbuminuria. LDL-C had to be > 2.5 mmol/l and the patient did not use any cholesterol lowering medication during the last 3 months preceding inclusion. The specialist made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca
Key exclusion criteria (1 listed)
- Exclusion criteria included patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases), patients with familial dyslipideamia like familial hypercholesterolaemia and familial combined hyperlipid
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 17 Dec 2007.
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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 study chair
CV
Ingeborg Vosjan study chair
CV
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 1 inclusion and 1 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 17 Dec 2007. 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 17 Dec 2007.