<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/NCT02232607</url>
  </required_header>
  <id_info>
    <org_study_id>231.339</org_study_id>
    <nct_id>NCT02232607</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Lacidipine in Chronic Stable Angina</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Lacidipine in Chronic Stable Angina.</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 was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg&#xD;
      decreased the symptoms of angina, compared to placebo in patients with chronic stable angina&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1998</start_date>
  <primary_completion_date type="Actual">June 1999</primary_completion_date>
  <phase>Phase 2</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>Change in total treadmill exercise duration</measure>
    <time_frame>Baseline, week 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in time to ST segment depression (≥ 0.1 mV)</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treadmill exercise time to first report of anginal pain</measure>
    <time_frame>week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for termination of treadmill exercise test</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency/severity of anginal attacks</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of short-acting nitrates</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">283</enrollment>
  <condition>Angina Pectoris</condition>
  <arm_group>
    <arm_group_label>Lacidipine, low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lacidipine, medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lacidipine, high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacidipine, low dose</intervention_name>
    <arm_group_label>Lacidipine, low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacidipine, medium dose</intervention_name>
    <arm_group_label>Lacidipine, medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacidipine, high dose</intervention_name>
    <arm_group_label>Lacidipine, high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Lacidipine, low dose</arm_group_label>
    <arm_group_label>Lacidipine, medium dose</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 80 years&#xD;
&#xD;
          -  History of stable, exertional angina pectoris (Canadian Cardiovascular Society&#xD;
             functional class II to III) for at least 3 months duration prior to enrolment in the&#xD;
             study&#xD;
&#xD;
          -  Patients not currently receiving treatment with antianginal medication (other than&#xD;
             short-acting nitrates)&#xD;
&#xD;
          -  Between visits 2 and 3 two treadmill exercise tests, demonstrating ≥ 0.1 mV of&#xD;
             horizontal or down sloping ST-segment depression, must be carried out. The difference&#xD;
             in symptom-limited exercise duration between these two tests must not exceed 20%&#xD;
&#xD;
          -  Total treadmill exercise duration &gt; 3 minutes (i.e. stage 2 or above on a standard&#xD;
             Bruce protocol)&#xD;
&#xD;
          -  Coronary artery disease, preferably (not mandatory) documented by a history of proven&#xD;
             myocardial infarction and/or coronary angiography indicating ≥ 50% reduction in&#xD;
             luminal diameter of one or more coronary arteries or their primary branches&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Myocardial infarction within 3 months prior to enrolment in the study&#xD;
&#xD;
          -  Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass&#xD;
             surgery within 6 months&#xD;
&#xD;
          -  Other types of angina (variant, unstable)&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure &gt; 180 mmHg or diastolic blood&#xD;
             pressure &gt; 100 mmHg)&#xD;
&#xD;
          -  Resting heart rate &lt; 50 bpm or &gt; 100 bpm&#xD;
&#xD;
          -  Significant valvular heart disease&#xD;
&#xD;
          -  Heart failure New York Heart Association Class III or IV&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease and/or asthma with clinical symptoms requiring&#xD;
             regular medication&#xD;
&#xD;
          -  Significant arrhythmia (since this may interfere with the interpretation of the&#xD;
             electrocardiogram) including Wolff Parkinson-White syndrome, atrial fibrillation,&#xD;
             atrial flutter, sick sinus syndrome, significant Atrio-Ventricular heart block,&#xD;
             intraventricular conduction defect (QRS &gt; 0.12 seconds) ventricular pre-excitation,&#xD;
             bundle branch block, the presence of a pace-maker, the presence of an implanted&#xD;
             automatic defibrillator, uncorrected hypokalaemia (potassium &lt; 3.5 mmol/litre)&#xD;
&#xD;
          -  Insulin dependent diabetes mellitus&#xD;
&#xD;
          -  Significant liver disease (Aspartate Aminotransferase or Alanine Aminotransferase &gt;&#xD;
             twice the upper limit of reference range)&#xD;
&#xD;
          -  Significant renal disease (creatinine &gt; 1.5 x upper limit of reference range)&#xD;
&#xD;
          -  Any clinical condition which in the opinion of the investigator, would preclude the&#xD;
             safe fulfilment of the protocol and the safe administration of trial medication&#xD;
&#xD;
          -  Inability to perform repeated exercise testing due to extra-cardiac reasons&#xD;
&#xD;
          -  Concomitant treatment with any other anti-anginal medication, whether or not&#xD;
             prescribed for this indication (e.g. calcium channel blockers, β-blockers or&#xD;
             long-acting nitrates)&#xD;
&#xD;
          -  Concomitant treatment with anti-arrhythmic medication, digitalis or tricyclic&#xD;
             anti-depressants or other agents known to affect ST-segment morphology&#xD;
&#xD;
          -  Known hypersensitivity to any of the components of the investigational drug&#xD;
&#xD;
          -  Pregnant or nursing women or women of child bearing potential&#xD;
&#xD;
          -  Participation in any other clinical trial within 2 months of enrolment&#xD;
&#xD;
          -  History of drug or alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</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 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 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>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacidipine</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/NCT02232607
org study id: 231.339
nct id: NCT02232607
lead sponsor: 
The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg
      decreased the symptoms of angina, compared to placebo in patients with chronic stable angina
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change in total treadmill exercise duration
time frame: Baseline, week 6
measure: Change in time to ST segment depression (≥ 0.1 mV)
time frame: up to 6 weeks
measure: Treadmill exercise time to first report of anginal pain
time frame: week 6
measure: Reason for termination of treadmill exercise test
time frame: up to 6 weeks
measure: Frequency/severity of anginal attacks
time frame: up to 6 weeks
measure: Consumption of short-acting nitrates
time frame: up to 6 weeks
measure: Number of patients with adverse events
time frame: up to 6 weeks
arm group label: Lacidipine, low dose
arm group type: Experimental
arm group label: Lacidipine, medium dose
arm group type: Experimental
arm group label: Lacidipine, high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Active Comparator
intervention type: Drug
intervention name: Lacidipine, low dose
arm group label: Lacidipine, low dose
intervention type: Drug
intervention name: Lacidipine, medium dose
arm group label: Lacidipine, medium dose
intervention type: Drug
intervention name: Lacidipine, high dose
arm group label: Lacidipine, high dose
intervention type: Drug
intervention name: Placebo
arm group label: Lacidipine, low dose
arm group label: Lacidipine, medium dose
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Angina Pectoris
mesh term: Angina, Stable
mesh term: Lacidipine