HyperlipidemiaNCT00934258
Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia
A study testing rosuvastatin,fenofibrate and CYP2C9, UGT1A1, UGT1A3, OATP2, BCRP in people with Hyperlipidemia, run by National Taiwan University Hospital.
Trial summary
Previous studies indicate that the variant status of detoxification proteins is different among Taiwanese and other ethnic groups. For example, in Taiwanese, the major SNPs of CYP2C9 are CYP2C9*2 (430C>T) and CYP2C9*3 (1075A>C) and their frequencies are different from that in Caucasians [11]. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- rosuvastatin,fenofibrate and CYP2C9, UGT1A1, UGT1A3, OATP2, BCRP
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 79 years
- All sexes
- Adult, Older adult
Who may be able to join
- Men or women aged 20-79 years with definite DM or atherosclerotic vascular diseases with metabolic syndrome, defined as the presence of three or more of the following risk factors:
- abdominal obesity (waist circumference > 90 cm in men or > 80 cm in women),
- triglycerides > 150 mg/dL, HDL-cholesterol < 40 mg/dL in men or < 50 mg/dL in women,
- blood pressure > 130/85 mm Hg, or
- fasting glucose > 100 mg/dL).
- Those who are qualified for lipid lowering therapy according to the Taiwanese national guidelines (LDL-C 130-190 mg/dL or TG 200-500 mg/dL with HDL-C < 40 mg/dL or TC/HDL-C > 5).
Who cannot join
- Any known contraindications to statin or fibrate therapy,
- Previous intolerance to statin or fibrate in low or high doses,
- Liver enzyme levels more than 3 times the upper limit of normal,
- Pregnancy or breastfeeding,
- Nephrotic syndrome,
- Uncontrolled diabetes mellitus (HbA1c > 9),
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- Uncontrolled hypothyroidism,
- Plasma LDL-C level higher than 190 mg/dL or triglyceride level higher than 500 mg/dL,
- Coronary heart disease event or revascularisation within a month,
- Congestive heart failure (New York Heart Association classification IIIb or IV),
- Hemodynamically important valvular heart disease,
- Gastrointestinal conditions affecting absorption of drugs,
- Treatment with other drugs that seriously affect the pharmacokinetics of statins or fibrate,
- Unexplained creatine phosphokinase concentrations six or more times the upper limit of normal,
- Life-threatening malignancy,
- Treatment with immuno suppressive or other lipid lowering drugs.
- Patients previously treated with monotherapy with statins or fibrates will be qualified if they have not already had titration to a dose higher than the equivalent of 5 mg/d of rosuvastatin or 160 mg/d of SFC fenofibrate.
Trial locations and contacts
No sites are listed yet.
About this study
Previous studies indicate that the variant status of detoxification proteins is different among Taiwanese and other ethnic groups. For example, in Taiwanese, the major SNPs of CYP2C9 are CYP2C9*2 (430C>T) and CYP2C9*3 (1075A>C) and their frequencies are different from that in Caucasians [11]. The second example is that the frequency of the A(TA)7TAA allele in the promoter area of the UGT1A1 gene is substantially lower, while for the rate of variation within the coding region is much higher in Taiwanese than that in Caucasians (14.3% vs. 35.7- 41.5% and 29.3% vs. 0.1%, respectively) [12]. The third example is that the frequency of 388A>G of the OATP2 gene in Taiwanese (0.68) [13] is in between that in European Americans (0.30) and African Americans (0.74) [14]. Therefore, the investigators hypothesize that, in Taiwanese the SNPs of detoxification proteins modulate the lipid-lowing effects of RVA and fenofibrate may be different from those for Caucasians.
Read the detailed description
Since April 2008, we have started to run a multicenter, prospective, randomized, open-label, blinded end-point classification trial to test the hypothesis in Taiwan that the addition of fibrate on statin would provide a further reduction in the major coronary events in the patients with diabetes or atherosclerotic vascular diseases with metabolic syndrome. With the advantage of this large-scaled prospective trial, it is also a good opportunity to identify simultaneously the genetic determinants of wide range of interindividual variability in phenotypic and clinical response to two major lipid-lowering drug classes, rosuvastatin and fenofibrate. The aim of this proposal is to find which SNPs influence the therapeutic effectiveness of lipid lowering therapy in Taiwanese hyperlipidemic patients. A key feature is the use of multiple drug-treated population samples to get the findings derived from both candidate gene and genome-wide searches for SNP associations with markers of drug efficacy as well as side effects. Thus the promise of pharmacogenomics and metabolomics-- "individualized medicine" will come true in treating hyperlipidemia in Taiwanese.
- Conditions
- Hyperlipidemia
- Being tested
- rosuvastatin,fenofibrate, CYP2C9, UGT1A1, UGT1A3, OATP2, BCRP
- Keywords
- genes, rosuvastatin, fenofibrate, Cardiovascular (CV) diseases, dyslipidemia, metabolic syndrome, identify genetic determinants of the wide range of interindividual variability in phenotypic and clinical response to the lipid-lowering drug classes, identify genetic susceptibility to drug-related side effects.
- Medical subject headings
- Hyperlipidemias, Disease, Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatin,fenofibrateDrug
Rosuvastatin 10 mg once daily Rosuvastatin 5 mg + SFC fenofibrate 80 mg
CYP2C9, UGT1A1, UGT1A3, OATP2, BCRPGenetic
All potential patients will be screened for the eligibility in a screening visit. Those who fill the inclusion criteria at screening will be invited for the registry study into different groups. The follow-up will take place at months 6, 12, 18, and every year thereafter for another 3 years, through clinical visiting, phone follow-up, or records from the NHIB Taiwan. At each clinical visit, vital signs, clinical endpoints, adverse events, concurrent medication information and laboratory specimens will be obtained as complete as possible. With phone or records from NHIB, only clinical endpoints will be recorded. If the primary care physician intends to treat the patient's lipid profile to the target, he/she can add, delete or adjust the LLT by his/her clinical judgement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934258
- Sponsor's protocol ID
- 200812111R
- Other IDs
- 200812111R
- Status last verified
- Nov 2012
- First submitted
- 6 Jul 2009
- Last updated
- 21 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00934258
- Acronym / sponsor ID
- 200812111R
- Conditions
- Hyperlipidemia
- Keywords
- genes, rosuvastatin, fenofibrate, Cardiovascular (CV) diseases, dyslipidemia, metabolic syndrome, identify genetic determinants of the wide range of interindividual variability in phenotypic and clinical response to the lipid-lowering drug classes, identify genetic susceptibility to drug-related side effects.
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- First posted
- 8 Jul 2009 (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.
Previous studies indicate that the variant status of detoxification proteins is different among Taiwanese and other ethnic groups. For example, in Taiwanese, the major SNPs of CYP2C9 are CYP2C9*2 (430C>T) and CYP2C9*3 (1075A>C) and their frequencies are different from that in Caucasians [11]. The second example is that the frequency of the A(TA)7TAA allele in the promoter area of the UGT1A1 gene is substantially lower, while for the rate of variation within the coding region is much higher in Taiwanese than that in Caucasians (14.3% vs. 35.7- 41.5% and 29.3% vs. 0.1%, respectively) [12]. The third example is that the frequency of 388A>G of the OATP2 gene in Taiwanese (0.68) [13] is in between that in European Americans (0.30) and African Americans (0.74) [14]. Therefore, the investigators hypothesize that, in Taiwanese the SNPs of detoxification proteins modulate the lipid-lowing effects of RVA and fenofibrate may be different from those for Caucasians.
Detailed description
Since April 2008, we have started to run a multicenter, prospective, randomized, open-label, blinded end-point classification trial to test the hypothesis in Taiwan that the addition of fibrate on statin would provide a further reduction in the major coronary events in the patients with diabetes or atherosclerotic vascular diseases with metabolic syndrome. With the advantage of this large-scaled prospective trial, it is also a good opportunity to identify simultaneously the genetic determinants of wide range of interindividual variability in phenotypic and clinical response to two major lipid-lowering drug classes, rosuvastatin and fenofibrate. The aim of this proposal is to find which SNPs influence the therapeutic effectiveness of lipid lowering therapy in Taiwanese hyperlipidemic patients. A key feature is the use of multiple drug-treated population samples to get the findings derived from both candidate gene and genome-wide searches for SNP associations with markers of drug efficacy as well as side effects. Thus the promise of pharmacogenomics and metabolomics-- "individualized medicine" will come true in treating hyperlipidemia in Taiwanese.
Study design
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women aged 20-79 years with definite DM or atherosclerotic vascular diseases with metabolic syndrome, defined as the presence of three or more of the following risk factors:
- Those who are qualified for lipid lowering therapy according to the Taiwanese national guidelines (LDL-C 130-190 mg/dL or TG 200-500 mg/dL with HDL-C < 40 mg/dL or TC/HDL-C > 5).
Key exclusion criteria (17 listed)
- Any known contraindications to statin or fibrate therapy,
- Previous intolerance to statin or fibrate in low or high doses,
- Liver enzyme levels more than 3 times the upper limit of normal,
- Pregnancy or breastfeeding,
- Nephrotic syndrome,
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 |
|---|---|---|
| rosuvastatin,fenofibrateRosuvastatin 10 mg once daily Rosuvastatin 5 mg + SFC fenofibrate 80 mg | Drug | – |
| CYP2C9, UGT1A1, UGT1A3, OATP2, BCRPAll potential patients will be screened for the eligibility in a screening visit. Those who fill the inclusion criteria at screening will be invited for the registry study into different groups. The follow-up will take place at months 6, 12, 18, and every year thereafter for another 3 years, through clinical visiting, phone follow-up, or records from the NHIB Taiwan. At each clinical visit, vital signs, clinical endpoints, adverse events, concurrent medication information and laboratory specimens will be obtained as complete as possible. With phone or records from NHIB, only clinical endpoints will be recorded. If the primary care physician intends to treat the patient's lipid profile to the target, he/she can add, delete or adjust the LLT by his/her clinical judgement | Genetic | – |
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 21 Dec 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing rosuvastatin,fenofibrate and CYP2C9, UGT1A1, UGT1A3, OATP2, BCRP in people with Hyperlipidemia, run by National Taiwan University Hospital.
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 6 inclusion and 17 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 21 Dec 2012. 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.
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 chau-chung Wu, Phd (+886-2-23123456 ext. 65428, chauchungwu@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 21 Dec 2012.