HypercholesterolemiaPhase 3NCT00654407
Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia
A Phase 3 study testing Rosuvastatin, Atorvastatin and Simvastatin in people with Hypercholesterolemia, run by AstraZeneca.
Trial summary
The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone. 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, Atorvastatin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,875 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Sep 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
- Discontinuation of all cholesterol lowing drugs, including dietary supplements.
- Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
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
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
- Abnormal laboratory parameters as defined in the protocol.
About this study
Official title: An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.
The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin, Atorvastatin, Simvastatin
- Keywords
- Cholesterol, hypercholesterolemia, Coronary Heart disease, low density lipoproteins, Rosuvastatin, Atorvastatin, simvastatin
- Medical subject headings
- Hypercholesterolemia, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
AtorvastatinDrug
Also called Lipitor
SimvastatinDrug
Also called Zocor
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rosuvastatin Receives: Drug: Rosuvastatin |
| 2 | Active comparator | Atorvastatin Receives: Drug: Atorvastatin |
| 3 | Active comparator | Simvastatin Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.
Measured: 16 weeks
Secondary outcomes (3)
Percentage change in other cholesterol & triglyceride measures
Measured: 16 weeks
Safety evaluation
Measured: 8 & 16 weeks
To compare the efficacy of rosuvastatin with atorvastatin and simvastatin
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 startNov 2001
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 4,875 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joel Raichlen, Study director, AstraZenecaRussell Esterline, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654407
- Sponsor's protocol ID
- 4522IL/0068
- Other IDs
- D3560C00068
- Status last verified
- Mar 2009
- First submitted
- 3 Apr 2008
- Last updated
- 16 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ballantyne CM, Raichlen JS, Cain VA. Statin therapy alters the relationship between apolipoprotein B and low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol targets in high-risk patients: the MERCURY II (Measuring Effective Reductions in Cholesterol Using Rosuvastatin) trial. J Am Coll Cardiol. 2008 Aug 19;52(8):626-32. doi: 10.1016/j.jacc.2008.04.052.
PubMed 18702965
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.
- ClinicalTrials.gov ID
- NCT00654407
- Acronym / sponsor ID
- 4522IL/0068
- Conditions
- Hypercholesterolemia
- Keywords
- Cholesterol, hypercholesterolemia, Coronary Heart disease, low density lipoproteins, Rosuvastatin, Atorvastatin, simvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,875 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Sep 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 determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RosuvastatinRosuvastatin |
| 2 | Active comparator | Drug: AtorvastatinAtorvastatin |
| 3 | Active comparator | Drug: SimvastatinSimvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Discontinuation of all cholesterol lowing drugs, including dietary supplements.
- Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
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
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
- Abnormal laboratory parameters as defined in the protocol.
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 | 1 |
| AtorvastatinAlso: Lipitor | Drug | 2 |
| SimvastatinAlso: Zocor | Drug | 3 |
Primary outcome
Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.
Time frame: 16 weeks
3 secondary outcomes
Percentage change in other cholesterol & triglyceride measures
Time frame: 16 weeks
Safety evaluation
Time frame: 8 & 16 weeks
To compare the efficacy of rosuvastatin with atorvastatin and simvastatin
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 16 Mar 2009.
- Derived from this study: PubMed 18702965Ballantyne CM, Raichlen JS, Cain VA. Statin therapy alters the relationship between apolipoprotein B and low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol targets in high-risk patients: the MERCURY II (Measuring Effective Reductions in Cholesterol Using Rosuvastatin) trial. J Am Coll Cardiol. 2008 Aug 19;52(8):626-32. doi: 10.1016/j.jacc.2008.04.052.
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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.
Joel Raichlen study director
AstraZeneca
Russell Esterline study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin, Atorvastatin and Simvastatin 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 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 16 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?
Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. (time frame: 16 weeks). 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 NCT00654407, which also lists 1 linked publication.
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 16 Mar 2009.