Primary HypercholesterolaemiaPhase 4NCT00396240
ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
A Phase 4 study testing Rosuvastatin and Initiatives to improve compliance in people with Primary Hypercholesterolaemia, run by AstraZeneca.
Trial summary
24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hypercholesterolaemia
- What is being tested?
- Rosuvastatin and Initiatives to improve compliance
- Type of treatment
- Surgery or procedure
- How many people
- 1,294 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to not given
- Phase
- Phase 4
- 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
- Primary hypercholesterolaemia:
- Statin naïve subjects (LDL-C level > 3.5 mmol/L) or subjects on an ineffective "start dose" of a lipid-lowering therapy (LDL-C level > 3.1 mmol/L).
- CV risk > 20%,
- history of CHD or other established atherosclerotic disease
Who cannot join
- History of severe adverse events with another HMG-CoA reductase inhibitor
- Secondary hypercholesterolaemia;
- Unstable cardiovascular disease;
- Uncontrolled diabetes, active liver disease;
- Severe hepatic or renal impairment;
- Treatment with cyclosporin.
About this study
24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.
- Conditions
- Primary Hypercholesterolaemia
- Being tested
- Rosuvastatin, Initiatives to improve compliance
- Keywords
- rosuvastatin, hypercholesterolaemia, cholesterol, LDL-C, triglyceride, plasma lipids, compliance
- Medical subject headings
- Hypercholesterolemia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Initiatives to improve complianceProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rosuvastatin therapy (10mg daily, titrated to 20mg at 12 weeks if necessary), alone or in combination with enhanced compliance initiatives, at 6 months, in bringing subjects with prim. hypercholesterolaemia to the EAS LDL-C target goals
Secondary outcomes (2)
To investigate the effect of rosuvastatin, both with and without compliance initiatives on number and percentage of subjects within the EAS or local LDL-C and TC target goals after 12 week therapy,
Safety of treatment.
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 2002
Why it stopped: study cancelled prior to FSI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- None (open label)
- Enrolment
- 1,294 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Madeleine Billeter, MD, Study director, AstraZenecaW. Riesen, MD, Principal investigator, Cantonal Hospital of St. GallenR. Darioli, MD, Principal investigator, CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396240
- Sponsor's protocol ID
- D3560L00008
- Other IDs
- ORBITAL
- Status last verified
- Mar 2009
- First submitted
- 3 Nov 2006
- Last updated
- 26 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
- ClinicalTrials.gov ID
- NCT00396240
- Acronym / sponsor ID
- D3560L00008
- Conditions
- Primary Hypercholesterolaemia
- Keywords
- rosuvastatin, hypercholesterolaemia, cholesterol, LDL-C, triglyceride, plasma lipids, compliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study cancelled prior to FSI
- Enrolment
- 1,294 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- 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.
24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (4 listed)
- Primary hypercholesterolaemia:
- Statin naïve subjects (LDL-C level > 3.5 mmol/L) or subjects on an ineffective "start dose" of a lipid-lowering therapy (LDL-C level > 3.1 mmol/L).
- CV risk > 20%,
- history of CHD or other established atherosclerotic disease
Key exclusion criteria (6 listed)
- History of severe adverse events with another HMG-CoA reductase inhibitor
- Secondary hypercholesterolaemia;
- Unstable cardiovascular disease;
- Uncontrolled diabetes, active liver disease;
- Severe hepatic or renal impairment;
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 |
|---|---|---|
| Rosuvastatin | Drug | – |
| Initiatives to improve compliance | Procedure or surgery | – |
Primary outcome
Comparison of the rosuvastatin therapy (10mg daily, titrated to 20mg at 12 weeks if necessary), alone or in combination with enhanced compliance initiatives, at 6 months, in bringing subjects with prim. hypercholesterolaemia to the EAS LDL-C target goals
2 secondary outcomes
To investigate the effect of rosuvastatin, both with and without compliance initiatives on number and percentage of subjects within the EAS or local LDL-C and TC target goals after 12 week therapy,
Safety of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2009.
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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.
Madeleine Billeter, MD study director
AstraZeneca
W. Riesen, MD principal investigator
Cantonal Hospital of St. Gallen
R. Darioli, MD principal investigator
CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and Initiatives to improve compliance in people with Primary Hypercholesterolaemia, 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 26 Mar 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Comparison of the rosuvastatin therapy (10mg daily, titrated to 20mg at 12 weeks if necessary), alone or in combination with enhanced compliance initiatives, at 6 months, in bringing subjects with prim. hypercholesterolaemia to the EAS LDL-C target goals. 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 26 Mar 2009.