Simvastatin Adverse ReactionNCT03261908
A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
An observational study of Simvastatin Adverse Reaction and Pharmacogenomics, run by Cui Yimin at 1 site in China.
Trial summary
Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups. There is still lack of research data in Chinese. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Simvastatin Adverse Reaction, Pharmacogenomics, Accurate Medication
- What is being tested?
- detection of genotype
- How many people
- 2,200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2018to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese Patients:In accordance with anti-hyperlipemia indications of simvastatin
Who may be able to join
- Patients taking simvastatin therapy
- Signed informed consent.
Who cannot join
- Patients not taking simvastatin therapy
- Intolerance or unwillingness to blood sample collection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Qian Xiang, Ph.D, +86 010 66110802, xiangqz@126.com
About this study
Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups. There is still lack of research data in Chinese. In this study, we will investigate whether there are specific genotypes which may predict the incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide a basis for developing guidelines on precise medication in simvastatin therapy apply to Chinese population.
- Being tested
- detection of genotype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detection of genotypeGenetic
detection of genotype by next generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| wild genotype | Through next generation sequencing, distinguish wild genotype of simvastatin Receives: Genetic: detection of genotype | |
| mutant genotype | Through next generation sequencing, distinguish mutant genotype of simvastatin Receives: Genetic: detection of genotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hepatic impairment
Measured: At 2 years
Incidence of myopathy
Measured: At 2 years
Secondary outcomes (1)
Genotype detected by next generation sequencing
Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing.
Measured: pre-dose of simvastatin(Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study startAug 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simvastatin Adverse ReactionStudies 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
- Other
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui Yimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261908
- Sponsor's protocol ID
- 2016[1237]
- Status last verified
- May 2018
- First submitted
- 23 Aug 2017
- Last updated
- 22 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
- ClinicalTrials.gov ID
- NCT03261908
- Acronym / sponsor ID
- 2016[1237]
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Aug 2017 (actual)
- 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.
Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups. There is still lack of research data in Chinese. In this study, we will investigate whether there are specific genotypes which may predict the incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide a basis for developing guidelines on precise medication in simvastatin therapy apply to Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wild genotype | – | Genetic: detection of genotypeThrough next generation sequencing, distinguish wild genotype of simvastatin |
| mutant genotype | – | Genetic: detection of genotypeThrough next generation sequencing, distinguish mutant genotype of simvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Patients:In accordance with anti-hyperlipemia indications of simvastatin
Key inclusion criteria (2 listed)
- Patients taking simvastatin therapy
- Signed informed consent.
Key exclusion criteria (2 listed)
- Patients not taking simvastatin therapy
- Intolerance or unwillingness to blood sample collection.
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 |
|---|---|---|
| detection of genotypedetection of genotype by next generation sequencing | Genetic | mutant genotype, wild genotype |
Primary outcome
Incidence of hepatic impairment
Time frame: At 2 years
Incidence of myopathy
Time frame: At 2 years
1 secondary outcome
Genotype detected by next generation sequencing
Time frame: pre-dose of simvastatin(Baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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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.
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 Simvastatin Adverse Reaction and Pharmacogenomics, run by Cui Yimin at 1 site in China.
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 2 inclusion and 2 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 22 May 2018. 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 China. 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 Qian Xiang, Ph.D (+86 010 66110802, xiangqz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hepatic impairment (time frame: At 2 years). 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 22 May 2018.