Suspended
Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency
What is being tested
somatropin
Drug
Who is being recruted
Bone Diseases+10
+ Bone Diseases, Developmental
+ Bone Diseases, Endocrine
From 12 to 25 Years
+4 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: May 2001
Summary
Principal SponsorNovo Nordisk A/S
Last updated: February 27, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: May 16, 2001
Actual date on which the first participant was enrolled.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).
Principal SponsorNovo Nordisk A/S
Last updated: February 27, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
7 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 12 to 25 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bone DiseasesBone Diseases, DevelopmentalBone Diseases, EndocrineBrain DiseasesCentral Nervous System DiseasesDwarfismEndocrine System DiseasesHypopituitarismHypothalamic DiseasesMusculoskeletal DiseasesNervous System DiseasesPituitary DiseasesDwarfism, Pituitary
Criteria
2 inclusion criteria required to participate
Adult growth hormone deficiency
At least 2 years without growth hormone treatment
2 exclusion criteria prevent from participating
Pregnancy
Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Novo Nordisk Investigational Site
Athens, GreeceOpen Novo Nordisk Investigational Site in Google MapsSuspendedOne Study Center