HypercholesteremiaPhase 4NCT00408382
Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque
A Phase 4 study testing atorvastatin, Lipitor in people with Hypercholesteremia and Coronary Artery Disease, run by Astellas Pharma Inc at 2 sites in Japan.
Trial summary
To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Hypercholesteremia, Coronary Artery Disease
- What is being tested?
- atorvastatin, Lipitor
- How many people
- 50 participants
- Where
- 2 sitesJapan
- Study dates
- Start not givento 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypercholesteremia
- The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected
Who cannot join
- Patients who has current administration of Lipitor or history of discontinued administration of Lipitor
- Acute cardiac infarction
Trial locations and contacts
2 sites in 1 country.
About this study
To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease
- Conditions
- Hypercholesteremia, Coronary Artery Disease
- Being tested
- atorvastatin, Lipitor
- Keywords
- Lipitor, atorvastatin, Hypercholesteremia, yellow coronary plaque
- Medical subject headings
- Hypercholesterolemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatin, LipitorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plaque characteristics as observed by coronary angioscopy
(the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)
Changes in the volume and the echogenicity as observed by intravascular ultrasound
Secondary outcomes (2)
Rate of change in serum lipid level
Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
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 HypercholesteremiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408382
- Sponsor's protocol ID
- A5481/HOP1
- Status last verified
- Dec 2006
- First submitted
- 5 Dec 2006
- Last updated
- 17 Nov 2011
- Results posted
- No
Publications
Hirayama A, Saito S, Ueda Y, Takayama T, Honye J, Komatsu S, Yamaguchi O, Li Y, Yajima J, Nanto S, Takazawa K, Kodama K. Qualitative and quantitative changes in coronary plaque associated with atorvastatin therapy. Circ J. 2009 Apr;73(4):718-25. doi: 10.1253/circj.cj-08-0755. Epub 2009 Feb 18.
PubMed 19225206
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque
- ClinicalTrials.gov ID
- NCT00408382
- Acronym / sponsor ID
- A5481/HOP1
- Conditions
- Hypercholesteremia, Coronary Artery Disease
- Keywords
- Lipitor, atorvastatin, Hypercholesteremia, yellow coronary plaque
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- First posted
- 6 Dec 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.
To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with hypercholesteremia
- The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected
Key exclusion criteria (2 listed)
- Patients who has current administration of Lipitor or history of discontinued administration of Lipitor
- Acute cardiac infarction
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 |
|---|---|---|
| atorvastatin, Lipitor | Drug | – |
Primary outcome
Changes in plaque characteristics as observed by coronary angioscopy
(the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)
Changes in the volume and the echogenicity as observed by intravascular ultrasound
2 secondary outcomes
Rate of change in serum lipid level
Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)
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 Nov 2011.
- Background: PubMed 19225206Hirayama A, Saito S, Ueda Y, Takayama T, Honye J, Komatsu S, Yamaguchi O, Li Y, Yajima J, Nanto S, Takazawa K, Kodama K. Qualitative and quantitative changes in coronary plaque associated with atorvastatin therapy. Circ J. 2009 Apr;73(4):718-25. doi: 10.1253/circj.cj-08-0755. Epub 2009 Feb 18.
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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.
Use Central Contact study director
Astellas Pharma Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atorvastatin, Lipitor in people with Hypercholesteremia and Coronary Artery Disease, run by Astellas Pharma Inc at 2 sites in Japan.
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 2 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 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Changes in plaque characteristics as observed by coronary angioscopy. The study lists 3 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 NCT00408382, 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 17 Nov 2011.