<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/NCT02187497</url>
  </required_header>
  <id_info>
    <org_study_id>502.268</org_study_id>
    <nct_id>NCT02187497</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of BIBR 277 in Hypertensive Patients</brief_title>
  <official_title>BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives&#xD;
      was evaluated. The results of the present study are to be used in the Japanese population&#xD;
      pharmacokinetics analysis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 1998</start_date>
  <primary_completion_date type="Actual">September 1998</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr)</measure>
    <time_frame>Pre-dose up to 24 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time of BIBR 277 in the body from 0 to 24 hours (MRT0-24hr)</measure>
    <time_frame>Pre-dose up to 24 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of BIBR 277 in plasma (Cmax)</measure>
    <time_frame>Pre-dose up to 24 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax)</measure>
    <time_frame>Pre-dose up to 24 hours after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal elimination half-time of BIBR 277 in plasma (t1/2)</measure>
    <time_frame>Pre-dose up to 24 hours after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in blood pressure (systolic, diastolic, and mean)</measure>
    <time_frame>Pre-dose up to 14 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in pulse rate</measure>
    <time_frame>Pre-dose up to 14 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 29 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in laboratory test values</measure>
    <time_frame>Pre-dose up to 14 days after start of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Low dose of BIBR 277</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dose of BIBR 277</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose of BIBR 277</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of BIBR 277</intervention_name>
    <arm_group_label>Low dose of BIBR 277</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medium dose of BIBR 277</intervention_name>
    <arm_group_label>Medium dose of BIBR 277</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of BIBR 277</intervention_name>
    <arm_group_label>High dose of BIBR 277</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: &gt;=20 years&#xD;
&#xD;
          -  Sex: Either male or female&#xD;
&#xD;
          -  Patient status: Either inpatient or outpatient, provided that the patient was&#xD;
             available for hospitalisation from the day before the trial medication administration&#xD;
             until the morning of the day after administration&#xD;
&#xD;
          -  BP: Sitting systolic and diastolic blood pressures (SBP and DBP) taken the day before&#xD;
             administration should be &gt;= 150 mmHg and &gt;= 90 mmHg, respectively. Patients undergoing&#xD;
             treatment with other antihypertensives were not excluded provided the above criteria&#xD;
             were satisfied.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malignant hypertension&#xD;
&#xD;
          -  Renovascular hypertension&#xD;
&#xD;
          -  Severe heart failure (NYHA functional class III - IV), unstable angina pectoris, or&#xD;
             history of myocardial infarction (within 6 months of onset)&#xD;
&#xD;
          -  Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or&#xD;
             serious arrhythmia&#xD;
&#xD;
          -  Symptoms of cerebrovascular disorder&#xD;
&#xD;
          -  Serious hepatic dysfunction&#xD;
&#xD;
          -  Renal function disorder (serum creatinine &gt;= 4.0 mg/dL)&#xD;
&#xD;
          -  Known hypersensitivity to angiotensin II receptor antagonists&#xD;
&#xD;
          -  Hyperkalaemia (potassium &gt;= 5.5 milliequivalents per liter (mEq/L))&#xD;
&#xD;
          -  Treatment with the other investigational drug within 6 months of initiation of the&#xD;
             present study&#xD;
&#xD;
          -  Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this&#xD;
             study&#xD;
&#xD;
          -  Previous treatment with the trial medication of the present study&#xD;
&#xD;
          -  Otherwise judged ineligible by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.268_U04-3141.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telmisartan</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/NCT02187497
org study id: 502.268
nct id: NCT02187497
lead sponsor: 
The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives
      was evaluated. The results of the present study are to be used in the Japanese population
      pharmacokinetics analysis
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr)
time frame: Pre-dose up to 24 hours after start of treatment
measure: Mean residence time of BIBR 277 in the body from 0 to 24 hours (MRT0-24hr)
time frame: Pre-dose up to 24 hours after start of treatment
measure: Maximum measured concentration of BIBR 277 in plasma (Cmax)
time frame: Pre-dose up to 24 hours after start of treatment
measure: Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax)
time frame: Pre-dose up to 24 hours after start of treatment
measure: Terminal elimination half-time of BIBR 277 in plasma (t1/2)
time frame: Pre-dose up to 24 hours after start of treatment
measure: Changes from baseline in blood pressure (systolic, diastolic, and mean)
time frame: Pre-dose up to 14 days after start of treatment
measure: Changes from baseline in pulse rate
time frame: Pre-dose up to 14 days after start of treatment
measure: Number of patients with adverse events
time frame: Up to 29 days
measure: Changes from baseline in laboratory test values
time frame: Pre-dose up to 14 days after start of treatment
arm group label: Low dose of BIBR 277
arm group type: Experimental
arm group label: Medium dose of BIBR 277
arm group type: Experimental
arm group label: High dose of BIBR 277
arm group type: Experimental
intervention type: Drug
intervention name: Low dose of BIBR 277
arm group label: Low dose of BIBR 277
intervention type: Drug
intervention name: Medium dose of BIBR 277
arm group label: Medium dose of BIBR 277
intervention type: Drug
intervention name: High dose of BIBR 277
arm group label: High dose of BIBR 277
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.268_U04-3141.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Telmisartan