HyperlipidemiasNCT00726362
To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia
An observational study of Hyperlipidemias, run by AstraZeneca at 8 sites in Taiwan.
Trial summary
The primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperlipidemias
- How many people
- 3,270 participants
- Where
- 8 sitesTaiwan
- Study dates
- Dec 2007to Nov 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: based on regular practice and judged by physicians, patients with hyperlipidemia who need to start prescribed with a statin; or to switch from current therapy to a statin, or require dosage adjustment for statin
Who may be able to join
- patients diagnosed with hyperlipidemia
- Patients who are just starting a statin treatment, who need to switch from current therapy to a statin medication, or who are receiving dosage adjustment of statin as judged by the physicians
- Patients who are willing to participate in this study and who sign an informed consent form
Who cannot join
- Pregnancy or breast feeding
- Patient are illiterate or unable to fill the questionnaire for any reason
- Patients with contraindications to the use of certain statins as needed prescribed by physicians (as per commercially available statins package insert) including the use of rosuvastatin.
- Any clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Research Site
Changhua
Research Site
Douliu
Research Site
Hualien City
Research Site
Kaohsiung City
Research Site
Pingtung City
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
About this study
The primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of usual clinical practice or captured upon its availability.
- Conditions
- Hyperlipidemias
- Keywords
- Statin, LDL-C
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with hyperlipidemia newly initiating a statin; or switched from current therapy to a statin, or require dosage adjustment for statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on LDL-C, HDL-C, TG, TC
Measured: 3~6 months
Secondary outcomes (3)
ratio for treatment-to-goal
Measured: 3~6 months
drug compliance
Measured: 3~6 months
correlation between patient's insight and therapeutic outcome
Measured: 3~6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wen-Ter Lai, MD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726362
- Sponsor's protocol ID
- NIS-CTW-CRE-2007/1
- Status last verified
- Dec 2010
- First submitted
- 29 Jul 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00726362
- Acronym / sponsor ID
- NIS-CTW-CRE-2007/1
- Conditions
- Hyperlipidemias
- Keywords
- Statin, LDL-C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,270 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 31 Jul 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 primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of usual clinical practice or captured upon its availability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with hyperlipidemia newly initiating a statin; or switched from current therapy to a statin, or require dosage adjustment for statin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- based on regular practice and judged by physicians, patients with hyperlipidemia who need to start prescribed with a statin; or to switch from current therapy to a statin, or require dosage adjustment for statin
Key inclusion criteria (3 listed)
- patients diagnosed with hyperlipidemia
- Patients who are just starting a statin treatment, who need to switch from current therapy to a statin medication, or who are receiving dosage adjustment of statin as judged by the physicians
- Patients who are willing to participate in this study and who sign an informed consent form
Key exclusion criteria (4 listed)
- Pregnancy or breast feeding
- Patient are illiterate or unable to fill the questionnaire for any reason
- Patients with contraindications to the use of certain statins as needed prescribed by physicians (as per commercially available statins package insert) including the use of rosuvastatin.
- Any clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes on LDL-C, HDL-C, TG, TC
Time frame: 3~6 months
3 secondary outcomes
ratio for treatment-to-goal
Time frame: 3~6 months
drug compliance
Time frame: 3~6 months
correlation between patient's insight and therapeutic outcome
Time frame: 3~6 months
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 3 Dec 2010.
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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.
Wen-Ter Lai, MD principal investigator
Kaohsiung Medical University
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 Hyperlipidemias, run by AstraZeneca at 8 sites in Taiwan.
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 3 Dec 2010. 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 Taiwan. 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 on LDL-C, HDL-C, TG, TC (time frame: 3~6 months). 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 3 Dec 2010.