RhabdomyolysisNCT00549029
The Association of Genetic Polymorphisms With Statin-Induced Myopathy.
An observational study of Rhabdomyolysis and Myopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To observe not only the distribution of single nucleotide polymorphism in genes related with pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the correlation between these SNPs and the incidence of statins-induced myopathy. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhabdomyolysis, Myopathy
- What is being tested?
- DNA
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Jan 2008
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: National Taiwan University Hospital
Who may be able to join
- Clinical diagnosis of Rhabdomyolysis because of prescription with statins
Who cannot join
- Carnitine palmityl transferase ll deficiency
- McArdle disease
- Myoadenylate deaminase deficiency
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yen-Hui Chen, PhD, 886-2-2312-3456 ext. 8397, tcyhchen@ntu.edu.tw
Tzung-Dau Wang, PhD, 886-2-2312-3456 ext. 5632, tdwang@ntu.edu.tw
About this study
Official title: Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients
To observe not only the distribution of single nucleotide polymorphism in genes related with pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the correlation between these SNPs and the incidence of statins-induced myopathy.
Read the detailed description
Statins are widely prescribed for the patients with hypercholesterolemia.
Though their efficacy in preventing cardiovascular events has been shown by a large number of clinical trials, myotoxic side effects including myopathy or even more severe,rhabdomyolysis are associated with the use of statins.
Because the incidence of myopathy is various among individuals,polymorphism in genes is supposed to be the main factor.
Due to single nucleotide polymorphism in related genes,level of uptake, clearance and metabolism of statins can be seriously different among individuals resulting in various occurrence of myopathy.
Therefore, analytical study in association between SNP of statins-related genes and the incidence of myopathy is such a critical research which can be applied into clinical fields.
- Conditions
- Rhabdomyolysis, Myopathy
- Being tested
- DNA
- Keywords
- muscle disorder, statins, creatine kinase
- Medical subject headings
- Rhabdomyolysis, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNAGenetic
withdraw 5~10mL blood from vein only once during the whole design
| Study group | Role | What they receive |
|---|---|---|
| 1,2 | Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy Receives: Genetic: DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
genotype of specific genes
Measured: one day
Secondary outcomes (1)
single nucleotide polymorphism
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startAug 2007
- Study completionJan 2008 (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 RhabdomyolysisStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yen-Hui Chen, PhD, Study director, National Taiwan Univesity College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549029
- Sponsor's protocol ID
- 200708077R
- Status last verified
- Oct 2007
- First submitted
- 24 Oct 2007
- Last updated
- 25 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Jisun Oh, et al. Genetic determinants of statin intolerance. Lipid in Health and Disease 2007;6(7). Wei Zhang, et al. Role of BCRP 421C>A polymorphism on rosuvastatin pharmacokinetics in healthy Chinese males. Clinica Chimica Acta 2006;373:99-103. Mikko Niemi, et al. Association of genetic polymorphism in ABCC2 with hepatic multidrug resistance-associated protein 2 expression and pravastatin pharmacokinetics. Pharmacogenetics and Genomics 2006;16:801-808. Andre' BM, et al. Association of polymorphism in the cytochrome CYP2D6 and the efficacy and tolerability of simvastatin. Clin Pharmacol Ther 2001;70:546-551. K. Morimoto, et al. OATP-C(OATPO1B1)15 IS ASSOCIATED WITH LESTEROLEMIC PATIENTS. CLINICAL PHARMACOLOGY THERAPEUTICS 2005;77(2). K. Morimoto, et al. CANDIDATE OF GENETIC MARKERS FOR STATIN-INDUCED MYOPATHY IN JAPANESE PATIENTS WITH HYPERCHOLESTEROLEMIA. Drug Metabolism Reviews 2005;37(4):345.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients
- ClinicalTrials.gov ID
- NCT00549029
- Acronym / sponsor ID
- 200708077R
- Conditions
- Rhabdomyolysis, Myopathy
- Keywords
- muscle disorder, statins, creatine kinase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Jan 2008 (estimated)
- First posted
- 25 Oct 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.
To observe not only the distribution of single nucleotide polymorphism in genes related with pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the correlation between these SNPs and the incidence of statins-induced myopathy.
Detailed description
Statins are widely prescribed for the patients with hypercholesterolemia.
Though their efficacy in preventing cardiovascular events has been shown by a large number of clinical trials, myotoxic side effects including myopathy or even more severe,rhabdomyolysis are associated with the use of statins.
Because the incidence of myopathy is various among individuals,polymorphism in genes is supposed to be the main factor.
Due to single nucleotide polymorphism in related genes,level of uptake, clearance and metabolism of statins can be seriously different among individuals resulting in various occurrence of myopathy.
Therefore, analytical study in association between SNP of statins-related genes and the incidence of myopathy is such a critical research which can be applied into clinical fields.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1,2 | – | Genetic: DNAGroup 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- National Taiwan University Hospital
Key inclusion criteria (1 listed)
- Clinical diagnosis of Rhabdomyolysis because of prescription with statins
Key exclusion criteria (3 listed)
- Carnitine palmityl transferase ll deficiency
- McArdle disease
- Myoadenylate deaminase deficiency
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 |
|---|---|---|
| DNAwithdraw 5~10mL blood from vein only once during the whole design | Genetic | 1,2 |
Primary outcome
genotype of specific genes
Time frame: one day
1 secondary outcome
single nucleotide polymorphism
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2007.
- BackgroundJisun Oh, et al. Genetic determinants of statin intolerance. Lipid in Health and Disease 2007;6(7). Wei Zhang, et al. Role of BCRP 421C>A polymorphism on rosuvastatin pharmacokinetics in healthy Chinese males. Clinica Chimica Acta 2006;373:99-103. Mikko Niemi, et al. Association of genetic polymorphism in ABCC2 with hepatic multidrug resistance-associated protein 2 expression and pravastatin pharmacokinetics. Pharmacogenetics and Genomics 2006;16:801-808. Andre' BM, et al. Association of polymorphism in the cytochrome CYP2D6 and the efficacy and tolerability of simvastatin. Clin Pharmacol Ther 2001;70:546-551. K. Morimoto, et al. OATP-C(OATPO1B1)15 IS ASSOCIATED WITH LESTEROLEMIC PATIENTS. CLINICAL PHARMACOLOGY THERAPEUTICS 2005;77(2). K. Morimoto, et al. CANDIDATE OF GENETIC MARKERS FOR STATIN-INDUCED MYOPATHY IN JAPANESE PATIENTS WITH HYPERCHOLESTEROLEMIA. Drug Metabolism Reviews 2005;37(4):345.
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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.
Yen-Hui Chen, PhD study director
National Taiwan Univesity College of Medicine
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 Rhabdomyolysis and Myopathy, 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 1 inclusion and 3 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 25 Oct 2007. 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 Yen-Hui Chen, PhD (886-2-2312-3456 ext. 8397, tcyhchen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genotype of specific genes (time frame: one day). 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 NCT00549029, 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 25 Oct 2007.