Back to resultsCardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency
Primary Purpose
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Status
Terminated
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Disorder
Eligibility Criteria
Inclusion Criteria:
- Adult growth hormone deficiency
- At least 2 years without growth hormone treatment
Exclusion Criteria:
- Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic
- Pregnancy
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Somatropin
Arm Description
Outcomes
Primary Outcome Measures
Left Ventricular systolic function
Left Ventricular diastolic function
Secondary Outcome Measures
Body composition
Fasting glucose
HbA1c (glycosylated haemoglobin)
Oral glucose tolerance test (OGTT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01698944
Brief Title
Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency
Official Title
Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
The trial was prematurely terminated due to low recruitment
Study Start Date
May 16, 2001 (Actual)
Primary Completion Date
November 18, 2002 (Actual)
Study Completion Date
November 18, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Disorder, Adult Growth Hormone Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Somatropin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention 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
Primary Outcome Measure Information:
Title
Left Ventricular systolic function
Title
Left Ventricular diastolic function
Secondary Outcome Measure Information:
Title
Body composition
Title
Fasting glucose
Title
HbA1c (glycosylated haemoglobin)
Title
Oral glucose tolerance test (OGTT)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult growth hormone deficiency
At least 2 years without growth hormone treatment
Exclusion Criteria:
Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency
We'll reach out to this number within 24 hrs