HypercholesterolemiaPhase 3NCT00379249
Rosuvastatin ORBITAL Germany
A Phase 3 study testing Rosuvastatin in people with Hypercholesterolemia, run by AstraZeneca.
Trial summary
The primary objective of the study is to compare the effect of rosuvastatin therapy plus compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term cumulative direct and indirect disease-related costs during the 36 month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Feb 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
- high cholesterol with an indication for cholesterol-lowering medication (statins)
Who cannot join
- contra-indications for statin therapy
About this study
Official title: Effects of a Twelve Months ROSUVASTATIN Treatment Plus Additional Care (Drug Intake Adherence and Lifestyle Enhancing Initiatives ) Compared to ROSUVASTATIN Treatment Alone on Long-Term Disease-Related Costs in Patients With an Indication for Statin Treatment According to the Joint European Guidelines
The primary objective of the study is to compare the effect of rosuvastatin therapy plus compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term cumulative direct and indirect disease-related costs during the 36 month.
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin
- Keywords
- hypercholesterolemia, statin, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative direct/indirect disease-related costs were compared applying a societal perspective
Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)
Secondary outcomes (2)
Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)
Changes in the lipid profile and compliance with therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startFeb 2002
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,000 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang Meyer - Sabellek, MD, Study director, AstraZeneca GermanyStefan Stefan Willich, MD, Principal investigator, Charité Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379249
- Sponsor's protocol ID
- D3560L00001
- Other IDs
- ORBITAL
- Status last verified
- Mar 2009
- First submitted
- 20 Sep 2006
- Last updated
- 26 Mar 2009
- Results posted
- No
Publications
Muckelbauer R, Englert H, Rieckmann N, Chen CM, Wegscheider K, Voller H, Katus HA, Willich SN, Muller-Nordhorn J. Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial. Prev Med. 2015 Aug;77:155-61. doi: 10.1016/j.ypmed.2015.05.026. Epub 2015 Jun 4.
PubMed 26051201Muller-Nordhorn J, Muckelbauer R, Englert H, Grittner U, Berger H, Sonntag F, Voller H, Prugger C, Wegscheider K, Katus HA, Willich SN. Longitudinal association between body mass index and health-related quality of life. PLoS One. 2014 Mar 26;9(3):e93071. doi: 10.1371/journal.pone.0093071. eCollection 2014.
PubMed 24671104
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
- Effects of a Twelve Months ROSUVASTATIN Treatment Plus Additional Care (Drug Intake Adherence and Lifestyle Enhancing Initiatives ) Compared to ROSUVASTATIN Treatment Alone on Long-Term Disease-Related Costs in Patients With an Indication for Statin Treatment According to the Joint European Guidelines
- ClinicalTrials.gov ID
- NCT00379249
- Acronym / sponsor ID
- D3560L00001
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, statin, compliance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,000 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- Feb 2004 (actual)
- First posted
- 21 Sep 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.
The primary objective of the study is to compare the effect of rosuvastatin therapy plus compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term cumulative direct and indirect disease-related costs during the 36 month.
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 (1 listed)
- high cholesterol with an indication for cholesterol-lowering medication (statins)
Key exclusion criteria (1 listed)
- contra-indications for statin therapy
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 | – |
Primary outcome
Cumulative direct/indirect disease-related costs were compared applying a societal perspective
Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)
2 secondary outcomes
Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)
Changes in the lipid profile and compliance with therapy.
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 26 Mar 2009.
- Derived from this study: PubMed 26051201Muckelbauer R, Englert H, Rieckmann N, Chen CM, Wegscheider K, Voller H, Katus HA, Willich SN, Muller-Nordhorn J. Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial. Prev Med. 2015 Aug;77:155-61. doi: 10.1016/j.ypmed.2015.05.026. Epub 2015 Jun 4.
- Derived from this study: PubMed 24671104Muller-Nordhorn J, Muckelbauer R, Englert H, Grittner U, Berger H, Sonntag F, Voller H, Prugger C, Wegscheider K, Katus HA, Willich SN. Longitudinal association between body mass index and health-related quality of life. PLoS One. 2014 Mar 26;9(3):e93071. doi: 10.1371/journal.pone.0093071. eCollection 2014.
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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.
Wolfgang Meyer - Sabellek, MD study director
AstraZeneca Germany
Stefan Stefan Willich, MD principal investigator
Charité Berlin, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin in people with Hypercholesterolemia, 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 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 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?
Cumulative direct/indirect disease-related costs were compared applying a societal perspective. The study lists 2 primary outcomes in all. 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 NCT00379249, which also lists 2 linked publications.
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; AzTrials last refreshed its copy on 30 Oct 2026.