<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/NCT02187484</url>
  </required_header>
  <id_info>
    <org_study_id>502.266</org_study_id>
    <nct_id>NCT02187484</nct_id>
  </id_info>
  <brief_title>BIBR 277 Capsules in Hypertensive Patients With Nephropathy</brief_title>
  <official_title>BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy</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 antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were&#xD;
      evaluated in hypertensive patients with nephropathy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 1998</start_date>
  <primary_completion_date type="Actual">August 1999</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in hypertensive effect by investigator, using a 5-grade classification</measure>
    <time_frame>8 weeks after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in blood pressure reduction</measure>
    <time_frame>8 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of blood pressure normalisation</measure>
    <time_frame>8 weeks after start of treatment</time_frame>
    <description>percentage of patients with &lt; 150/90 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in blood pressure / pulse rate</measure>
    <time_frame>8 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usefulness assessment by investigator, using a 5- grade classification</measure>
    <time_frame>8 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall safety assessment by investigator, using a 5- grade classification</measure>
    <time_frame>8 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory values</measure>
    <time_frame>Up to 8 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Single rising doses of BIBR 277</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBR 277</intervention_name>
    <arm_group_label>Single rising doses of BIBR 277</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Condition: Either of the following criteria is satisfied in laboratory tests:&#xD;
&#xD;
               -  Presence of a renal parenchymal disorder such as chronic glomerulonephritis is&#xD;
                  confirmed (serum creatinine &lt; 3.0 mg/dL)&#xD;
&#xD;
               -  Presence of a renal function disorder (serum creatinine ≥ 1.5 mg/dL to &lt; 3.0&#xD;
                  mg/dL)&#xD;
&#xD;
          -  Age: ≥ 20 years&#xD;
&#xD;
          -  Sex: Either male or female&#xD;
&#xD;
          -  Patient status: Either outpatients or inpatients. However, the patient status should&#xD;
             remain unchanged throughout the study period&#xD;
&#xD;
          -  Blood pressure (BP):&#xD;
&#xD;
               -  [Outpatients] The last 2 measurements of sitting BP out of at least 3 taken&#xD;
                  during the observation period (2 - 4 weeks) should be stable and a mean of the&#xD;
                  two measurements should be ≥160 mmHg for systolic BP (SBP) and ≥95 mmHg for&#xD;
                  diastolic BP (DBP)&#xD;
&#xD;
               -  [Inpatients] The last 2 measurements of supine BP taken during the observation&#xD;
                  period (1 week) should be stable and a mean of the 2 measurements should be ≥ 150&#xD;
                  mmHg for SBP and ≥ 90 mmHg for DBP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renovascular hypertension&#xD;
&#xD;
          -  Undergoing haemodialysis&#xD;
&#xD;
          -  Severe hypertension (Diastolic BP ≥ 120 mmHg)&#xD;
&#xD;
          -  Severe heart failure, angina pectoris, or history of myocardial infarction&#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;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Peptic ulcer&#xD;
&#xD;
          -  History of hypersensitivity to drugs&#xD;
&#xD;
          -  Hyperkalaemia&#xD;
&#xD;
          -  Undergoing treatment with a digitalis preparation&#xD;
&#xD;
          -  Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this&#xD;
             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/502/502.266_U04-3224.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/NCT02187484
org study id: 502.266
nct id: NCT02187484
lead sponsor: 
The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were
      evaluated in hypertensive patients with nephropathy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes from baseline in hypertensive effect by investigator, using a 5-grade classification
time frame: 8 weeks after start of treatment
measure: Changes from baseline in blood pressure reduction
time frame: 8 weeks after start of treatment
measure: Rate of blood pressure normalisation
time frame: 8 weeks after start of treatment
description: percentage of patients with < 150/90 mmHg
measure: Changes from baseline in blood pressure / pulse rate
time frame: 8 weeks after start of treatment
measure: Usefulness assessment by investigator, using a 5- grade classification
time frame: 8 weeks after start of treatment
measure: Overall safety assessment by investigator, using a 5- grade classification
time frame: 8 weeks after start of treatment
measure: Number of patients with adverse events
time frame: Up to 12 weeks
measure: Number of patients with abnormal changes in laboratory values
time frame: Up to 8 weeks after start of treatment
arm group label: Single rising doses of BIBR 277
arm group type: Experimental
intervention type: Drug
intervention name: BIBR 277
arm group label: Single rising doses 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/502/502.266_U04-3224.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Telmisartan