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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01698944
Date of registration: 01/10/2012
Prospective Registration: No
Primary sponsor: Novo Nordisk A/S
Public title: Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency
Scientific title: Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency
Date of first enrolment: May 16, 2001
Target sample size: 7
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01698944
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Greece
Contacts
Name:     Global Clinical Registry (GCR, 1452)
Address: 
Telephone:
Email:
Affiliation:  Novo Nordisk A/S
Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 25 Years
Gender: All
Health Condition(s) or Problem(s) studied
Adult Growth Hormone Deficiency
Growth Hormone Disorder
Intervention(s)
Drug: somatropin
Primary Outcome(s)
Left Ventricular diastolic function
Left Ventricular systolic function
Secondary Outcome(s)
Body composition
Fasting glucose
HbA1c (glycosylated haemoglobin)
Oral glucose tolerance test (OGTT)
Secondary ID(s)
GHDADULT-1112
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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