<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/NCT02244255</url>
  </required_header>
  <id_info>
    <org_study_id>527.17</org_study_id>
    <nct_id>NCT02244255</nct_id>
  </id_info>
  <brief_title>FLOMAX® Versus HYTRIN® in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia</brief_title>
  <official_title>An Eleven-Week, Open-Label, Randomized, Multicenter, Parallel-Design, Placebo Lead-in Study of FLOMAX® Capsules, 0.4 mg Daily Versus HYTRIN® Capsules, 5 mg (With Titration) Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      1. To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg&#xD;
           daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the&#xD;
           signs and symptoms of benign prostatic hyperplasia (BPH)&#xD;
&#xD;
        2. To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in&#xD;
           comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the&#xD;
           symptoms of benign prostatic hyperplasia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 1998</start_date>
  <primary_completion_date type="Actual">June 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in American Urological Association (AUA) symptom score index</measure>
    <time_frame>Pre-dose, up to day 57 after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in AUA bother score index</measure>
    <time_frame>Pre-dose, up to 57days after start of treatment</time_frame>
    <description>Validated quality of life questionnaire for urinary problems containing:&#xD;
AUA obstructive symptom score&#xD;
AUA irritative symptom score&#xD;
AUA nocturia symptom score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in BPH impact index score</measure>
    <time_frame>Pre-dose, up to 57 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment by investigator on a 5-point scale</measure>
    <time_frame>Day 5, up to day 57 after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes from baselinein laboratory values</measure>
    <time_frame>Pre-dose, day 57 after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>Pre-dose, up to 57 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically relevant changes from baseline in ECG</measure>
    <time_frame>Pre-dose, up to 57 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to day 57</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1993</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>FLOMAX®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HYTRIN®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FLOMAX® capsules</intervention_name>
    <arm_group_label>FLOMAX®</arm_group_label>
    <other_name>Tamsulosin hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ascending doses of HYTRIN® capsules</intervention_name>
    <arm_group_label>HYTRIN®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients (45 years of age or older) diagnosed with benign prostatic hyperplasia&#xD;
&#xD;
          -  Patients with a total score on the AUA Symptom Index for BPH of at least 13 points at&#xD;
             each of the three initial visits (Visits 1, 2 and 3)&#xD;
&#xD;
          -  A baseline prostate specific antigen (PSA) of ≤ 4.0 ng/ml&#xD;
&#xD;
          -  Patients who are able to give written informed consent before performing screening&#xD;
             examinations or tests&#xD;
&#xD;
          -  Patients being judged by the investigator to be reliable and able to follow protocol&#xD;
             procedures (including the return visits schedule), and cooperate in the completion of&#xD;
             tests related to safety and efficacy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of an allergy to alpha blockers, alpha/beta blockers or&#xD;
             patients who have had a &quot;first dose hypotensive episode&quot; upon starting therapy with an&#xD;
             alpha blocker&#xD;
&#xD;
          -  Patients who are currently being treated or who, in the last 3 months, have been&#xD;
             treated with finasteride&#xD;
&#xD;
          -  Participated in an investigational drug study within 4 weeks prior to starting placebo&#xD;
             phase&#xD;
&#xD;
          -  Patients taking medication in the following classes and unable to discontinue them at&#xD;
             least two weeks before the study and for the duration of the study&#xD;
&#xD;
               -  Alpha adrenergic blocking agents&#xD;
&#xD;
               -  Alpha adrenergic agonists&#xD;
&#xD;
               -  Drugs with anticholinergic activity (including antihistamines)&#xD;
&#xD;
               -  Antispasmodics&#xD;
&#xD;
               -  Parasympathomimetics and cholinomimetics&#xD;
&#xD;
          -  Peripheral or central neurologic disease including, but not limited to, transient&#xD;
             ischemic attacks, stroke, dementia, multiple sclerosis, spinal cord injury, recurrent&#xD;
             episodes of dizziness, vertigo, or loss of consciousness, clinically evident diabetic&#xD;
             neuropathy, brain and/or spinal cord tumors&#xD;
&#xD;
          -  History of a pathological fall (unintentional change in body position) occurring under&#xD;
             circumstances in which normal homeostatic mechanisms would ordinarily maintain&#xD;
             stability, or syncope during the last year&#xD;
&#xD;
          -  More than one episode of angina within the past 6 months&#xD;
&#xD;
          -  Ambulation requiring assistance (i.e., canes, walkers, etc.)&#xD;
&#xD;
          -  Documented myocardial infarction (by ECG) within the past 6 months or evidence of a&#xD;
             myocardial infarction on ECG whose age cannot be determined&#xD;
&#xD;
          -  New York Heart Association Class III or IV congestive heart failure&#xD;
&#xD;
          -  Prosthetic heart valves, cardiac devices or prior history of endocarditis&#xD;
&#xD;
          -  Clinically significant cardiac arrhythmias either diagnosed by ECG or recorded in the&#xD;
             medical history, whether or not accompanied by symptoms (e.g., dizziness, presyncope,&#xD;
             syncope, unsteadiness)&#xD;
&#xD;
          -  Infravesical obstruction by history due to:&#xD;
&#xD;
               -  Vesical neck contracture&#xD;
&#xD;
               -  Clinical suspicion of prostate carcinoma&#xD;
&#xD;
               -  Mullerian duct cysts&#xD;
&#xD;
               -  Urethral obstruction due to stricture, valves, sclerosis or urethral tumor&#xD;
&#xD;
               -  Inflammatory or infectious conditions&#xD;
&#xD;
               -  Detrusor-sphincter dyssynergia&#xD;
&#xD;
          -  Prior transurethral resection of the prostate (TURP) or open prostatectomy&#xD;
&#xD;
          -  History of instrumentation of the urinary tract (cytoscopy or catheterization) within&#xD;
             30 days prior to the start of the study&#xD;
&#xD;
          -  Prior pelvic surgery for malignancy or bowel resection&#xD;
&#xD;
          -  History or diagnosis of genitourinary malignancy&#xD;
&#xD;
          -  History of an episode of acute urinary retention within three months prior to the&#xD;
             start of the study. (Urinary retention is to be considered acute if the patient has to&#xD;
             be sent to a hospital for catheterization)&#xD;
&#xD;
          -  Patients with the current diagnosis of either bladder, ureter, or kidney stones&#xD;
&#xD;
          -  Patients with a current diagnosis of suspected prostatitis&#xD;
&#xD;
          -  Patients with a history of a neurogenic bladder&#xD;
&#xD;
          -  Urinary tract infection (i.e., positive urine culture) yielding pathogenic bacteria &gt;&#xD;
             10**5 colony forming units (CFU) per milliliter in a properly obtained clean voided&#xD;
             urine specimen which has been properly cultured or a laboratory report of a urinary&#xD;
             tract infection or signs/symptoms indicative of a urinary tract infection such as&#xD;
             [increased WBC's in the urine (15-30 white blood cells (WBC)/high powered field),&#xD;
             dysuria, costovertebral tenderness, and urinary frequency accompanied by fever] within&#xD;
             four weeks of baseline (Visit 3)&#xD;
&#xD;
          -  Evidence of significant renal dysfunction based upon a serum creatinine greater than&#xD;
             two times the upper limit of normal levels established by the central laboratory used&#xD;
             in this study&#xD;
&#xD;
          -  Laboratory tests during the screening phase:&#xD;
&#xD;
               -  Hemoglobin: &lt; 12.0 g/dL&#xD;
&#xD;
               -  Leukocytes: &lt; 3000/mm3&#xD;
&#xD;
               -  Liver Enzymes: (serum glutamic oxaloacetic transaminase (SGOT), serum glutamate&#xD;
                  pyruvate transaminase (SGPT), and alkaline phosphatase): more than two times the&#xD;
                  upper limit of normal levels established by the central laboratory used in the&#xD;
                  study&#xD;
&#xD;
          -  Clinically relevant conditions which might interfere with the patient's ability to&#xD;
             participate in the study including, but not limited to, the following: neurologic,&#xD;
             gastrointestinal, cardiovascular including uncontrolled hypertension defined as a&#xD;
             sitting diastolic blood pressure ≥ 95 mmHg with or without treatment, hepatic, renal,&#xD;
             psychiatric, hematologic or respiratory disease, clinically relevant laboratory&#xD;
             abnormalities based upon the investigator's judgment&#xD;
&#xD;
          -  Hypertensive patients initially using HYTRIN® as a monotherapy for both hypertension&#xD;
             and BPH&#xD;
&#xD;
          -  Patients with cancer or diagnosis of cancer within five years of baseline&#xD;
&#xD;
          -  Patients who have been receiving cimetidine, warfarin, or herbal medications&#xD;
             specifically for treatment of any urological problems within four weeks prior to the&#xD;
             baseline&#xD;
&#xD;
          -  Patients who show poor compliance in the initial placebo period by:&#xD;
&#xD;
               -  not returning unused medication bottles for Visits 2 or 3&#xD;
&#xD;
               -  having taken &lt; 80% or &gt; 120% of prescribed doses during any visit interval&#xD;
                  between Visit (1, 2 or 3)&#xD;
&#xD;
          -  Postural symptoms during the initial placebo period, e.g., lightheadedness (on more&#xD;
             than three occasions), fainting, blurring or loss of vision, profound weakness, or&#xD;
             unsteadiness, with or without a change in blood pressure and/or pulse rate&#xD;
&#xD;
          -  Patients with poorly controlled diabetes mellitus (urine positive for glucose (&gt; 1+)&#xD;
             on each of 2 urinalyses during the placebo evaluation period)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 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 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 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>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</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/NCT02244255
org study id: 527.17
nct id: NCT02244255
lead sponsor: 
1. To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg
           daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the
           signs and symptoms of benign prostatic hyperplasia (BPH)

        2. To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in
           comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the
           symptoms of benign prostatic hyperplasia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in American Urological Association (AUA) symptom score index
time frame: Pre-dose, up to day 57 after start of treatment
measure: Changes in AUA bother score index
time frame: Pre-dose, up to 57days after start of treatment
description: Validated quality of life questionnaire for urinary problems containing:
AUA obstructive symptom score
AUA irritative symptom score
AUA nocturia symptom score
measure: Changes in BPH impact index score
time frame: Pre-dose, up to 57 days after start of treatment
measure: Global assessment by investigator on a 5-point scale
time frame: Day 5, up to day 57 after start of treatment
measure: Number of patients with clinically relevant changes from baselinein laboratory values
time frame: Pre-dose, day 57 after start of treatment
measure: Number of patients with clinically significant changes in vital signs
time frame: Pre-dose, up to 57 days after start of treatment
measure: Number of patients with clinically relevant changes from baseline in ECG
time frame: Pre-dose, up to 57 days after start of treatment
measure: Number of patients with adverse events
time frame: Up to day 57
arm group label: FLOMAX®
arm group type: Experimental
arm group label: HYTRIN®
arm group type: Active Comparator
intervention type: Drug
intervention name: FLOMAX® capsules
arm group label: FLOMAX®
other name: Tamsulosin hydrochloride
intervention type: Drug
intervention name: Ascending doses of HYTRIN® capsules
arm group label: HYTRIN®
criteria: 
gender: Male
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Tamsulosin