HypercholesterolemiaALWAYSNCT01446679
Special Drug Use-Results Survey of Lipitor Tablets
An observational study of Hypercholesterolemia, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- atrovastatin
- Type of treatment
- Pill or oral medicine
- How many people
- 24,050 participants
- Where
- 8 sitesJapan
- Study dates
- Sep 2010to Mar 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hypercholesterolemia who have not achieved the category-specific target lipid level in other statin therapies
Patients with hypercholesterolemia who have not achieved the category-specific target lipid level
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.
Read the detailed description
To confirm the low-density lipoprotein cholesterol (LDL-C)-lowering effect of 24 weeks of treatment with Lipitor®(Generic Name : atorvastatin calcium) Tablets and determine the rate of achievement of the category-specific target LDL-C level in patients with hypercholesterolemia; and to confirm the usefulness (efficacy and safety) of atorvastatin in patients who have not responded sufficiently to other statin therapies
- Conditions
- Hypercholesterolemia
- Being tested
- atrovastatin
- Keywords
- Lipitor, HMG-CoA reductase inhibitor
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atrovastatinDrug
Also called Lipitor
oral
| Study group | Role | What they receive |
|---|---|---|
| atrovastatin group | Who receive atrovastatin Receives: Drug: atrovastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma LDL-C concentration
Measured: 0, 4, 12 and 24 week
Change in rate of achievement of the category-specific target LDL-C level
Measured: 0, 4, 12 and 24 week
Secondary outcomes (2)
Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL])
Measured: 0, 4, 12 and 24 week
Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine)
Measured: 0, 4, 12 and 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionMar 2012
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contract, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446679
- Sponsor's protocol ID
- LIP003
- Acronym
- ALWAYS
- Status last verified
- Feb 2013
- First submitted
- 22 Sep 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use-Results Survey of Lipitor Tablets
- ClinicalTrials.gov ID
- NCT01446679
- Acronym / sponsor ID
- ALWAYS / LIP003
- Conditions
- Hypercholesterolemia
- Keywords
- Lipitor, HMG-CoA reductase inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,050 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 Oct 2011 (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.
This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.
Detailed description
To confirm the low-density lipoprotein cholesterol (LDL-C)-lowering effect of 24 weeks of treatment with Lipitor®(Generic Name : atorvastatin calcium) Tablets and determine the rate of achievement of the category-specific target LDL-C level in patients with hypercholesterolemia; and to confirm the usefulness (efficacy and safety) of atorvastatin in patients who have not responded sufficiently to other statin therapies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atrovastatin group | – | Drug: atrovastatinWho receive atrovastatin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hypercholesterolemia who have not achieved the category-specific target lipid level in other statin therapies
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 |
|---|---|---|
| atrovastatinAlso: Lipitororal | Drug | atrovastatin group |
Primary outcome
Changes in plasma LDL-C concentration
Time frame: 0, 4, 12 and 24 week
Change in rate of achievement of the category-specific target LDL-C level
Time frame: 0, 4, 12 and 24 week
2 secondary outcomes
Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL])
Time frame: 0, 4, 12 and 24 week
Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine)
Time frame: 0, 4, 12 and 24 week
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 21 Feb 2013.
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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 Contract study chair
Astellas Pharma Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Astellas Pharma Inc at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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 plasma LDL-C concentration (time frame: 0, 4, 12 and 24 week). 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?
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 21 Feb 2013.