<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/NCT03259399</url>
  </required_header>
  <id_info>
    <org_study_id>2016[1238]</org_study_id>
    <nct_id>NCT03259399</nct_id>
  </id_info>
  <brief_title>A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.</brief_title>
  <official_title>A Study of Genetic Variants Associated With Enalapril-Induced Adverse Drug Reaction and Impact of Pharmacogenomics on First Stroke in Hypertensive Patients Taking Enalapril or Enalapril-Folic Acid Therapy.</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>
      Dry cough is the most common adverse reaction of angiotensin converting enzyme, including&#xD;
      enalapril, in Chinese population. Clinical observations suggest that the incidence of&#xD;
      ACEI-induced dry cough is different between Chinese and other racial groups, however, there&#xD;
      is still lack of research data in Chinese. Stroke is the second leading cause of death in the&#xD;
      world and leading cause of death in China. Except the known risk factor such as hypertension,&#xD;
      high homocysteine level, folic acid deficiency, the impact of genetics should not be ignored.&#xD;
&#xD;
      In this study, we will investigate whether there are specific genotypes which may predict the&#xD;
      incidence of (1)enalapril-induced dry cough in Chinese and (2)first stroke in hypertensive&#xD;
      patients taking enalapril or enalapril-folic acid therapy, so as to provide a basis for&#xD;
      developing guidelines on precision medication in enalapril therapy apply to Chinese&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</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 dry cough</measure>
    <time_frame>At 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>First Incidence of stroke</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 enalapril or enalapril-folic acid (Baseline)</time_frame>
    <description>Collect blood specimen before enalapril administration, then detect genotype of enalapril by next generation sequencing.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2200</enrollment>
  <condition>Enalapril Adverse Reaction</condition>
  <condition>Pharmacogenomics</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>wild genotype</arm_group_label>
    <description>Detection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mutant genotype</arm_group_label>
    <description>Detection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril</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-hypertension indications of enalapril&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients taking enalapril or enalapril-folic acid therapy&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not taking enalapril treated&#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>August 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</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>Stroke</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/NCT03259399
org study id: 2016[1238]
nct id: NCT03259399
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Dry cough is the most common adverse reaction of angiotensin converting enzyme, including
      enalapril, in Chinese population. Clinical observations suggest that the incidence of
      ACEI-induced dry cough is different between Chinese and other racial groups, however, there
      is still lack of research data in Chinese. Stroke is the second leading cause of death in the
      world and leading cause of death in China. Except the known risk factor such as hypertension,
      high homocysteine level, folic acid deficiency, the impact of genetics should not be ignored.

      In this study, we will investigate whether there are specific genotypes which may predict the
      incidence of (1)enalapril-induced dry cough in Chinese and (2)first stroke in hypertensive
      patients taking enalapril or enalapril-folic acid therapy, so as to provide a basis for
      developing guidelines on precision medication in enalapril therapy apply to Chinese
      population.
observational model: Cohort
time perspective: Other
measure: Incidence of dry cough
time frame: At 2 years
measure: First Incidence of stroke
time frame: At 2 years
measure: Genotype detected by next generation sequencing
time frame: pre-dose of enalapril or enalapril-folic acid (Baseline)
description: Collect blood specimen before enalapril administration, then detect genotype of enalapril by next generation sequencing.
arm group label: wild genotype
description: Detection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril
arm group label: mutant genotype
description: Detection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril
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: Stroke