<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/NCT03009487</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DWJ1351003</org_study_id>
    <nct_id>NCT03009487</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daewoong Pharmaceutical Co. LTD.</source>
  <brief_summary>
    <textblock>
      A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy&#xD;
      and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with&#xD;
      concomitant hypertension and hyperlipidemia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change of sitSBP based on baseline between Treatment arm and control 1 arm</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the change of LDL-C based on baseline between Treatment arm and control2 arm</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">265</enrollment>
  <condition>Hypertension</condition>
  <condition>Hyperlipidemias</condition>
  <arm_group>
    <arm_group_label>Amlodpine, Olmesartan, Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>co-administration of Olmesartan, Amlodipine and Rosuvastatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olmesartan, Rosuvastatin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>co-administration of Olmesartan and Rosuvastatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amlodipine, Olmesartan</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>co-administration of Amlodipine and and Olmesartan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg</intervention_name>
    <description>co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg</description>
    <arm_group_label>Amlodpine, Olmesartan, Rosuvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olmesartan 40 mg, Rosuvastatin 20mg</intervention_name>
    <description>co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).</description>
    <arm_group_label>Olmesartan, Rosuvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine/Olmesartan 10/40mg (Combination drug)</intervention_name>
    <description>co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg</description>
    <arm_group_label>Amlodipine, Olmesartan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20 to 80 years&#xD;
&#xD;
          -  patients with hypertension and hyperlipidemias&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  orthostatic hypotension&#xD;
&#xD;
          -  History of ventricular tachycardia, atrial fibrillation&#xD;
&#xD;
          -  uncontrolled diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul national university bundang hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Olmesartan</mesh_term>
    <mesh_term>Olmesartan Medoxomil</mesh_term>
    <mesh_term>Amlodipine Besylate, Olmesartan Medoxomil Drug Combination</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_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/NCT03009487
org study id: DW_DWJ1351003
nct id: NCT03009487
lead sponsor: 
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy
      and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with
      concomitant hypertension and hyperlipidemia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: the change of sitSBP based on baseline between Treatment arm and control 1 arm
time frame: 8 weeks
measure: the change of LDL-C based on baseline between Treatment arm and control2 arm
time frame: 8 weeks
arm group label: Amlodpine, Olmesartan, Rosuvastatin
arm group type: Experimental
description: co-administration of Olmesartan, Amlodipine and Rosuvastatin
arm group label: Olmesartan, Rosuvastatin
arm group type: Placebo Comparator
description: co-administration of Olmesartan and Rosuvastatin
arm group label: Amlodipine, Olmesartan
arm group type: Placebo Comparator
description: co-administration of Amlodipine and and Olmesartan
intervention type: Drug
intervention name: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg
description: co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg
arm group label: Amlodpine, Olmesartan, Rosuvastatin
intervention type: Drug
intervention name: Olmesartan 40 mg, Rosuvastatin 20mg
description: co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).
arm group label: Olmesartan, Rosuvastatin
intervention type: Drug
intervention name: Amlodipine/Olmesartan 10/40mg (Combination drug)
description: co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg
arm group label: Amlodipine, Olmesartan
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
mesh term: Amlodipine
mesh term: Olmesartan
mesh term: Olmesartan Medoxomil
mesh term: Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
mesh term: Rosuvastatin Calcium