Statins, HMG-CoANCT00509574
Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy
An observational study of Statins, HMG-CoA and Single Nucleotide Polymorphism, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. However, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Statins, HMG-CoA, Single Nucleotide Polymorphism
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2007to Feb 2010
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hyperlipidemic patients meeting the criteria of NCEP ATPIII for drug treatment at internal medicine clinic of National Taiwan University Hospital.
Who may be able to join
- aged 21-80.
- conforms with the criteria of National Cholesterol Education Program Adult Treatment Panel III for medication therapy.
- have received atorvastatin or rosuvastatin regularly for 12 weeks or longer.
- available lipid profiles such triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol 12-24 weeks after staring statin therapy.
Who cannot join
- had been using lipid-lowering medications including statins 4 weeks before starting atorvastatin or rosuvastatin.
- received other lipid-lowering medications, erythromycin, immunosuppressant or azole antifungals concomitantly.
- pregnant, breast-feeding, or able to become pregnant.
- have a history of alcohol or substance abuse.
- liver cirrhosis or ALT exceeds the upper limit of normal range.
- untreated hypothyroidism.
Show all 9Show fewer
- patients with malignant tumor who have received chemotherapy or radiotherapy.
- known allergy to atorvastatin, rosuvastatin or other statins.
- unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
About this study
The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. However, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed to the variation.
Read the detailed description
Hyperlipidemic patients are retrospectively screened from 2006/1/1 to 2006/12/31. The patient is included if he or she had been receiving atorvastatin or rosuvastatin for at least 3 months and did not receive other lipid-lowering medications 4 weeks before starting atorvastatin or rosuvastatin. Genomic DNA was collected from the blood sample of each patient using genomic DNA purification kit. The single nucleotide polymorphisms (SNPs) were determined afterward.
The correlation between response of statin therapy, defined as changes in lipid profiles including triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol, and SNPs examined.
- Conditions
- Statins, HMG-CoA, Single Nucleotide Polymorphism
- Keywords
- Single Nucleotide Polymorphism, statins, hyperlipidemia
- Medical subject headings
- Hyperlipidemias
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startMar 2007
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statins, HMG-CoAStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tzung-Dau Wang, MD, PhD, Principal investigator, Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509574
- Sponsor's protocol ID
- 200702006M
- Status last verified
- Nov 2010
- First submitted
- 29 Jul 2007
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy
- ClinicalTrials.gov ID
- NCT00509574
- Acronym / sponsor ID
- 200702006M
- Conditions
- Statins, HMG-CoA, Single Nucleotide Polymorphism
- Keywords
- Single Nucleotide Polymorphism, statins, hyperlipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Feb 2010 (estimated)
- First posted
- 31 Jul 2007 (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 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. However, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed to the variation.
Detailed description
Hyperlipidemic patients are retrospectively screened from 2006/1/1 to 2006/12/31. The patient is included if he or she had been receiving atorvastatin or rosuvastatin for at least 3 months and did not receive other lipid-lowering medications 4 weeks before starting atorvastatin or rosuvastatin. Genomic DNA was collected from the blood sample of each patient using genomic DNA purification kit. The single nucleotide polymorphisms (SNPs) were determined afterward.
The correlation between response of statin therapy, defined as changes in lipid profiles including triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol, and SNPs examined.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hyperlipidemic patients meeting the criteria of NCEP ATPIII for drug treatment at internal medicine clinic of National Taiwan University Hospital.
Key inclusion criteria (4 listed)
- aged 21-80.
- conforms with the criteria of National Cholesterol Education Program Adult Treatment Panel III for medication therapy.
- have received atorvastatin or rosuvastatin regularly for 12 weeks or longer.
- available lipid profiles such triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol 12-24 weeks after staring statin therapy.
Key exclusion criteria (9 listed)
- had been using lipid-lowering medications including statins 4 weeks before starting atorvastatin or rosuvastatin.
- received other lipid-lowering medications, erythromycin, immunosuppressant or azole antifungals concomitantly.
- pregnant, breast-feeding, or able to become pregnant.
- have a history of alcohol or substance abuse.
- liver cirrhosis or ALT exceeds the upper limit of normal range.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
Tzung-Dau Wang, MD, PhD principal investigator
Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Statins, HMG-CoA and Single Nucleotide Polymorphism, run by National Taiwan University Hospital at 1 site 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzung-Dau Wang, MD, PhD (886-2-2312-3456 ext. 5632, tdwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Dec 2010.