<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/NCT02183285</url>
  </required_header>
  <id_info>
    <org_study_id>1209.1</org_study_id>
    <nct_id>NCT02183285</nct_id>
  </id_info>
  <brief_title>Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential</brief_title>
  <official_title>A 30 Day, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre Safety Trial to Evaluate the Tolerability Profile of Pharmaton PHL 00747 Soft Gelatine Capsules (Multivitamin, Multimineral + Omega-3 Fatty Acids) 1/Day p.o. and Pharmaton PHL 00747 Film-coated Tablets (Multivitamin, Multimineral Without Omega-3 Fatty Acids) 1/Day p.o. in Healthy, Young Female Subjects of Child-bearing Potential</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and&#xD;
      film-coated tablets&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2003</start_date>
  <primary_completion_date type="Actual">March 2004</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of total drug-related adverse events assessed by the investigator</measure>
    <time_frame>up to 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of all adverse events</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL)</measure>
    <time_frame>up to 44 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in vital signs (blood pressure and heart rate)</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall tolerability assessed by the subject and the investigator on a four-point rating scale</measure>
    <time_frame>day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale</measure>
    <time_frame>day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability of the trial medications by the subject</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PHL 00747 capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PHL 00747 tablets</arm_group_label>
    <arm_group_type>Experimental</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>Dietary Supplement</intervention_type>
    <intervention_name>Pharmaton PHL 00747 soft gelatine capsules</intervention_name>
    <arm_group_label>PHL 00747 capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pharmaton PHL 00747 film-coated tablets</intervention_name>
    <arm_group_label>PHL 00747 tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo film-coated tablets (fct)</intervention_name>
    <arm_group_label>PHL 00747 capsules</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo soft gelatine capsules</intervention_name>
    <arm_group_label>PHL 00747 tablets</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female out-patients of child-bearing potential&#xD;
&#xD;
          -  Ages ranging between 18 and 40 years&#xD;
&#xD;
          -  Willing and able to give written informed consent in accordance to Good Clinical&#xD;
             Practice (GCP) and local legislation prior to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to the use of any of the trial ingredients&#xD;
&#xD;
          -  Known hypersensitivity to any of the ingredients&#xD;
&#xD;
          -  Alcohol- or drug-addiction&#xD;
&#xD;
          -  Currently participation in another trial, or has participated in a trial within the&#xD;
             previous 30 days&#xD;
&#xD;
          -  Known abnormal values of the laboratory tests (if detected after enrolment, subjects&#xD;
             will continue the treatment provided there are no medical objections)&#xD;
&#xD;
          -  Already taking other mult-vitamin products during the last 2 weeks&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1209/1209.1_U04-1394.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02183285
org study id: 1209.1
nct id: NCT02183285
lead sponsor: 
To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and
      film-coated tablets
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Incidence of total drug-related adverse events assessed by the investigator
time frame: up to 30 days
measure: Incidence of all adverse events
time frame: up to 30 days
measure: Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL)
time frame: up to 44 days
measure: Changes from baseline in vital signs (blood pressure and heart rate)
time frame: up to 30 days
measure: Overall tolerability assessed by the subject and the investigator on a four-point rating scale
time frame: day 30
measure: Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale
time frame: day 30
measure: Tolerability of the trial medications by the subject
time frame: up to 30 days
arm group label: PHL 00747 capsules
arm group type: Experimental
arm group label: PHL 00747 tablets
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Pharmaton PHL 00747 soft gelatine capsules
arm group label: PHL 00747 capsules
intervention type: Dietary Supplement
intervention name: Pharmaton PHL 00747 film-coated tablets
arm group label: PHL 00747 tablets
intervention type: Dietary Supplement
intervention name: Placebo film-coated tablets (fct)
arm group label: PHL 00747 capsules
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Placebo soft gelatine capsules
arm group label: PHL 00747 tablets
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1209/1209.1_U04-1394.pdf
description: Related Info
responsible party type: Sponsor