<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/NCT01698944</url>
  </required_header>
  <id_info>
    <org_study_id>GHDADULT-1112</org_study_id>
    <nct_id>NCT01698944</nct_id>
  </id_info>
  <brief_title>Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency</brief_title>
  <official_title>Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in Europe. The aim of this trial is to investigate the effect of&#xD;
      growth hormone on left ventricle morphology and function (systolic and diastolic).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The trial was prematurely terminated due to low recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">May 16, 2001</start_date>
  <completion_date type="Actual">November 18, 2002</completion_date>
  <primary_completion_date type="Actual">November 18, 2002</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Left Ventricular systolic function</measure>
  </primary_outcome>
  <primary_outcome>
    <measure>Left Ventricular diastolic function</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c (glycosylated haemoglobin)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral glucose tolerance test (OGTT)</measure>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Growth Hormone Disorder</condition>
  <condition>Adult Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>Somatropin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>somatropin</intervention_name>
    <description>Initial dose 0.5 IU/day and escalated up to maximum dose the first 6 months. Maximum dose 3.0 IU/day for 18 months. Injected subcutaneously (s.c., under the skin) daily</description>
    <arm_group_label>Somatropin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult growth hormone deficiency&#xD;
&#xD;
          -  At least 2 years without growth hormone treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Athens</city>
        <zip>GR-11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>February 23, 2017</last_update_submitted>
  <last_update_submitted_qc>February 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2017</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>Dwarfism, Pituitary</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_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/NCT01698944
org study id: GHDADULT-1112
nct id: NCT01698944
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to investigate the effect of
      growth hormone on left ventricle morphology and function (systolic and diastolic).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Left Ventricular systolic function
measure: Left Ventricular diastolic function
measure: Body composition
measure: Fasting glucose
measure: HbA1c (glycosylated haemoglobin)
measure: Oral glucose tolerance test (OGTT)
arm group label: Somatropin
arm group type: Experimental
intervention type: Drug
intervention name: somatropin
description: Initial dose 0.5 IU/day and escalated up to maximum dose the first 6 months. Maximum dose 3.0 IU/day for 18 months. Injected subcutaneously (s.c., under the skin) daily
arm group label: Somatropin
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Greece
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Dwarfism, Pituitary
mesh term: Endocrine System Diseases