<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/NCT02235402</url>
  </required_header>
  <id_info>
    <org_study_id>231.336</org_study_id>
    <nct_id>NCT02235402</nct_id>
  </id_info>
  <brief_title>A Randomised, Parallel-group, Double-blind, Double-dummy Study to Compare the Effects of Lacidipine Versus Bendrofluazide on Markers of Platelet Activation and Haemorheological Factors in Hypertensive Patients</brief_title>
  <official_title>A Randomised, Parallel-group, Double-blind, Double-dummy Study to Compare the Effects of Lacidipine Versus Bendrofluazide on Markers of Platelet Activation and Haemorheological Factors in 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 aim of this study is to compare the effects of lacidipine on markers of platelet&#xD;
      activation and other rheological factors in hypertensive patients with those of&#xD;
      bendrofluazide&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 1997</start_date>
  <primary_completion_date type="Actual">March 2000</primary_completion_date>
  <phase>Phase 4</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</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in ß-TG (thromboglobulin)</measure>
    <time_frame>Up to week 12 after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in soluble p-selectin</measure>
    <time_frame>Up to week 12 after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in rheological factors</measure>
    <time_frame>Up to week 12 after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lipid levels between randomisation and last visit</measure>
    <time_frame>Up to week 12 after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in laboratory parameters</measure>
    <time_frame>Up to week 12 after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to week 12 after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Lacidipine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Bendrofluazide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacidipine</intervention_name>
    <arm_group_label>Lacidipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendrofluazide</intervention_name>
    <arm_group_label>Bendrofluazide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or over&#xD;
&#xD;
          -  Hypertensive at screening: Diastolic blood pressure (DBP) 95 - 115 mm Hg and / or&#xD;
             systolic blood pressure (SBP) &gt;= 160 mm Hg on no therapy or on monotherapy. If&#xD;
             currently on monotherapy, DBP could have been &lt; 95 mm Hg and SBP &lt; 160 mm Hg, but the&#xD;
             patient must have been experiencing unacceptable side effects from their current&#xD;
             treatment. Patient must then be able to stop treatment for the placebo run in phase of&#xD;
             four weeks without endangering their health (at investigator's discretion)&#xD;
&#xD;
          -  Hypertensive at randomisation: DBP 95-115 mm Hg and or SBP &gt;=160&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Grad III or grad IV hypertensive retinopathy&#xD;
&#xD;
          -  Renal impairment; serum creatinine &gt; 150 µmol/L&#xD;
&#xD;
          -  Heart failure. (New York Heart Association (NYHA) Class III or IV)&#xD;
&#xD;
          -  Liver impairment (abnormal Liver function test (LFT) with aspartate-amino transferase&#xD;
             (AST) / alanine-amino transferase (ALT) &gt; 2x upper normal limit or bilirubin &gt; 2x&#xD;
             upper normal limit)&#xD;
&#xD;
          -  Recent (&lt; 2 months) history of unstable angina&#xD;
&#xD;
          -  Recent (&lt; 2 months) history of myocardial infarction&#xD;
&#xD;
          -  Recent (&lt; 2 months) history of stroke&#xD;
&#xD;
          -  History of diabetes mellitus or impaired glucose tolerance or random blood glucose &gt;=&#xD;
             9 mMol/L&#xD;
&#xD;
          -  Any acute systemic illness or infection&#xD;
&#xD;
          -  Any severe disease which could interfere with survival or well-being during the study&#xD;
             (e.g. malignancy)&#xD;
&#xD;
          -  Patients of child bearing potential&#xD;
&#xD;
          -  Current or previous drug and / or alcohol abuse&#xD;
&#xD;
          -  Severely limited venous access&#xD;
&#xD;
          -  Haemoglobin &lt; 10g/dL (male patients), haemoglobin &lt; 9g/dL (female patients)&#xD;
&#xD;
          -  Requirement for anticoagulant therapy&#xD;
&#xD;
          -  Severe valvular heart disease (investigator's discretion)&#xD;
&#xD;
          -  Atrial fibrillation or other serious cardiac dysrhythmia&#xD;
&#xD;
          -  History of thyroid disease or abnormal thyroid function test (thyroid stimulating&#xD;
             hormone (TSH) &lt; 0.4 mU/L or &gt; 5.4 mU/L)&#xD;
&#xD;
          -  History of connective tissue disorder&#xD;
&#xD;
          -  Concurrent participation in any other clinical trial or participation within two&#xD;
             months enrolment&#xD;
&#xD;
          -  Requirement for restricted drugs&#xD;
&#xD;
          -  Patients currently on treatment with lacidipine or bendrofluazide (BNFZ)&#xD;
&#xD;
          -  Patients unable to attend clinics&#xD;
&#xD;
          -  Any clinical condition which in the opinion of the investigator, would preclude the&#xD;
             safe fulfillment of the protocol and the safe administration of trial medication&#xD;
&#xD;
          -  Seated blood pressure (BP) exceeding either 210 mm Hg (systolic) or 115 mm Hg&#xD;
             (diastolic) at screening or randomization&#xD;
&#xD;
          -  Standing BP &lt; 140 mm Hg (systolic) and &lt; 95 mm Hg (diastolic) at randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 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>Lacidipine</mesh_term>
    <mesh_term>Bendroflumethiazide</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/NCT02235402
org study id: 231.336
nct id: NCT02235402
lead sponsor: 
The aim of this study is to compare the effects of lacidipine on markers of platelet
      activation and other rheological factors in hypertensive patients with those of
      bendrofluazide
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Changes in ß-TG (thromboglobulin)
time frame: Up to week 12 after drug administration
measure: Changes in soluble p-selectin
time frame: Up to week 12 after drug administration
measure: Changes in rheological factors
time frame: Up to week 12 after drug administration
measure: Changes in lipid levels between randomisation and last visit
time frame: Up to week 12 after drug administration
measure: Number of patients with clinical significant findings in laboratory parameters
time frame: Up to week 12 after drug administration
measure: Number of patients with adverse events
time frame: Up to week 12 after drug administration
arm group label: Lacidipine
arm group type: Experimental
arm group label: Bendrofluazide
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Lacidipine
arm group label: Lacidipine
intervention type: Drug
intervention name: Bendrofluazide
arm group label: Bendrofluazide
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Lacidipine
mesh term: Bendroflumethiazide