HypercholesterolemiaPhase 3EXPLORERNCT00653445
Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg
A Phase 3 study testing Rosuvastatin and Ezetimibe in people with Hypercholesterolemia and Coronary Heart Disease, run by AstraZeneca.
Trial summary
The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
- What is being tested?
- Rosuvastatin and Ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jun 2005
- 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
- A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
- Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
- Discontinuation of all lipid lowering therapy at Visit 1.
Who cannot join
- History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
- Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
- Severe congestive cardiac failure (as defined by the protocol - Appendix I).
- Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..
About this study
Official title: A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%).
The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.
- Being tested
- Rosuvastatin, Ezetimibe
- Keywords
- Low density lipoproteins, Hypercholesterolemia, Coronary Heart Disease, Rosuvastatin, Crestor, Ezetimibe
- Medical subject headings
- Hypercholesterolemia, Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
40mg
EzetimibeDrug
Also called Zetia
10mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rosuvastatin 40mg/Ezetimibe 10mg combination therapy Receives: Drug: Rosuvastatin; Drug: Ezetimibe |
| 2 | Experimental | Rosuvastatin 40 mg Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6
Secondary outcomes (2)
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6
Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startJun 2004
- Study completionJun 2005
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christine Ballantyne, MD, Principal investigator, Centre for prevention of cardiovascular disease, Texas, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653445
- Sponsor's protocol ID
- D3569C00006
- Acronym
- EXPLORER
- Status last verified
- Mar 2009
- First submitted
- 2 Apr 2008
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- 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
- A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%).
- ClinicalTrials.gov ID
- NCT00653445
- Acronym / sponsor ID
- EXPLORER / D3569C00006
- Keywords
- Low density lipoproteins, Hypercholesterolemia, Coronary Heart Disease, Rosuvastatin, Crestor, Ezetimibe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Jun 2005 (actual)
- First posted
- 7 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 compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rosuvastatin, Drug: EzetimibeRosuvastatin 40mg/Ezetimibe 10mg combination therapy |
| 2 | Experimental | Drug: RosuvastatinRosuvastatin 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
- Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
- Discontinuation of all lipid lowering therapy at Visit 1.
Key exclusion criteria (4 listed)
- History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
- Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
- Severe congestive cardiac failure (as defined by the protocol - Appendix I).
- Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..
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: Crestor40mg | Drug | 1, 2 |
| EzetimibeAlso: Zetia10mg | Drug | 1 |
Primary outcome
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6
2 secondary outcomes
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6
Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe
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.
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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.
Christine Ballantyne, MD principal investigator
Centre for prevention of cardiovascular disease, Texas, USA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin and Ezetimibe in people with 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 3 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 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?
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6. 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.