<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/NCT01712997</url>
  </required_header>
  <id_info>
    <org_study_id>BIPH-20121022</org_study_id>
    <nct_id>NCT01712997</nct_id>
  </id_info>
  <brief_title>Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients</brief_title>
  <acronym>BIPH</acronym>
  <official_title>Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies suggest that combinations of existing therapies may be effective for&#xD;
      pulmonary arterial hypertension (PAH). However, all of these studies are sequential&#xD;
      combination therapy, for example, by adding sildenafil to previously prescribed bosentan.&#xD;
      This kind of therapy model is not enough for PAH patients, especially those with New York&#xD;
      Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the&#xD;
      investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin&#xD;
      analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH&#xD;
      by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in&#xD;
      6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and&#xD;
      time to clinical worsening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">September 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in 6-min-walk distance (6-MWD)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified (NYHA) functional class</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>time to clinical worsening</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>Combination therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bosentan,125mg,po,bid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iloprost</intervention_name>
    <arm_group_label>Combination therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bosentan</intervention_name>
    <arm_group_label>Combination therapy</arm_group_label>
    <arm_group_label>monotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 10 to 80&#xD;
&#xD;
          -  treatment naive symptomatic PAH&#xD;
&#xD;
          -  6-MWD of 100-425 m&#xD;
&#xD;
          -  resting mean pulmonary artery pressure greater than 25 mm Hg, pulmonary capillary&#xD;
             wedge pressure less than 15 mm Hg, and pulmonary vascular resistance of 240 dyn.s.cm-5&#xD;
             or greater.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with thromboembolic disease,&#xD;
&#xD;
          -  untreated obstructive sleep apnea,&#xD;
&#xD;
          -  portal hypertension,&#xD;
&#xD;
          -  chronic liver disease or renal insufficiency,&#xD;
&#xD;
          -  left-sided or unrepaired congenital heart disease,&#xD;
&#xD;
          -  substantial obstructive (FEV1/FVC&lt;50% predicted) or restrictive (total lung&#xD;
             capacity&lt;60% predicted) lung disease&#xD;
&#xD;
          -  Patients receiving phosphodiesterase inhibitors or other prostanoids and endothelin&#xD;
             receptor antagonists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shengqing Li, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The department of pulmonary and critical care medicine, Xijing hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shengqing Li, MD, PhD</last_name>
    <phone>+86-29-84771132</phone>
    <email>shengqingli@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The department of pulmonary and critical care medicine, Tangdu hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yonghong Xie, MD</last_name>
      <phone>+86-29-84777725</phone>
      <email>xieyh65@yahoo.com.cn</email>
    </contact>
    <investigator>
      <last_name>Yonghong Xie, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The department of pulmonary and critical care medicine, Xijing hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinpeng Han, MD</last_name>
      <phone>+86-29-84775237</phone>
      <email>hxp0728@163.com</email>
    </contact>
    <investigator>
      <last_name>Xinpeng Han, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yongping Yu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>February 26, 2014</last_update_submitted>
  <last_update_submitted_qc>February 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Shengqing Li</investigator_full_name>
    <investigator_title>Associate Chief Physician, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Treatment of</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bosentan</mesh_term>
    <mesh_term>Iloprost</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>April 23, 2016</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>July 7, 2016</submitted>
    <returned>August 18, 2016</returned>
  </pending_results>
  <!-- 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/NCT01712997
org study id: BIPH-20121022
nct id: NCT01712997
lead sponsor: 
has dmc: Yes
Previous studies suggest that combinations of existing therapies may be effective for
      pulmonary arterial hypertension (PAH). However, all of these studies are sequential
      combination therapy, for example, by adding sildenafil to previously prescribed bosentan.
      This kind of therapy model is not enough for PAH patients, especially those with New York
      Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the
      investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin
      analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH
      by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in
      6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and
      time to clinical worsening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change from baseline in 6-min-walk distance (6-MWD)
time frame: 12 weeks
measure: modified (NYHA) functional class
time frame: 12 weeks
measure: time to clinical worsening
time frame: 2 years
arm group label: Combination therapy
arm group type: Experimental
description: combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
arm group label: monotherapy
arm group type: Active Comparator
description: Bosentan,125mg,po,bid.
intervention type: Drug
intervention name: Iloprost
arm group label: Combination therapy
intervention type: Drug
intervention name: Bosentan
arm group label: Combination therapy
arm group label: monotherapy
criteria: 
gender: All
minimum age: 10 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shengqing Li, MD, PhD
role: Principal Investigator
affiliation: The department of pulmonary and critical care medicine, Xijing hospital
last name: Shengqing Li, MD, PhD
phone: +86-29-84771132
email: shengqingli@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Shengqing Li
investigator title: Associate Chief Physician, Associate Professor
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
mesh term: Bosentan
mesh term: Iloprost
submitted: April 23, 2016
submission canceled: Unknown
submitted: July 7, 2016
returned: August 18, 2016