<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03261908</url>
  </required_header>
  <id_info>
    <org_study_id>2016[1237]</org_study_id>
    <nct_id>NCT03261908</nct_id>
  </id_info>
  <brief_title>A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction</brief_title>
  <official_title>A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cui Yimin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of&#xD;
      simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese&#xD;
      population than other racial groups. There is still lack of research data in Chinese. In this&#xD;
      study, we will investigate whether there are specific genotypes which may predict the&#xD;
      incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide&#xD;
      a basis for developing guidelines on precise medication in simvastatin therapy apply to&#xD;
      Chinese population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 2018</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of hepatic impairment</measure>
    <time_frame>At 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of myopathy</measure>
    <time_frame>At 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genotype detected by next generation sequencing</measure>
    <time_frame>pre-dose of simvastatin(Baseline)</time_frame>
    <description>Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2200</enrollment>
  <condition>Simvastatin Adverse Reaction</condition>
  <condition>Pharmacogenomics</condition>
  <condition>Accurate Medication</condition>
  <arm_group>
    <arm_group_label>wild genotype</arm_group_label>
    <description>Through next generation sequencing, distinguish wild genotype of simvastatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mutant genotype</arm_group_label>
    <description>Through next generation sequencing, distinguish mutant genotype of simvastatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>detection of genotype</intervention_name>
    <description>detection of genotype by next generation sequencing</description>
    <arm_group_label>mutant genotype</arm_group_label>
    <arm_group_label>wild genotype</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese Patients:In accordance with anti-hyperlipemia indications of simvastatin&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients taking simvastatin therapy&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not taking simvastatin therapy&#xD;
&#xD;
          -  Intolerance or unwillingness to blood sample collection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qian Xiang, Ph.D</last_name>
    <phone>+86 010 66110802</phone>
    <email>xiangqz@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qian Xiang, Ph.D</last_name>
      <phone>+86 010 66110802</phone>
      <email>xiangqz@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>May 18, 2018</last_update_submitted>
  <last_update_submitted_qc>May 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Cui Yimin</investigator_full_name>
    <investigator_title>Director of pharmacy，M.D &amp; Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03261908
org study id: 2016[1237]
nct id: NCT03261908
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Other
measure: Incidence of hepatic impairment
time frame: At 2 years
measure: Incidence of myopathy
time frame: At 2 years
measure: Genotype detected by next generation sequencing
time frame: pre-dose of simvastatin(Baseline)
description: Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing.
arm group label: wild genotype
description: Through next generation sequencing, distinguish wild genotype of simvastatin
arm group label: mutant genotype
description: Through next generation sequencing, distinguish mutant genotype of simvastatin
intervention type: Genetic
intervention name: detection of genotype
description: detection of genotype by next generation sequencing
arm group label: mutant genotype
arm group label: wild genotype
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Qian Xiang, Ph.D
phone: +86 010 66110802
email: xiangqz@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Cui Yimin
investigator title: Director of pharmacy，M.D & Ph.D
mesh term: Drug-Related Side Effects and Adverse Reactions