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Clinical Trials/NCT01698944
NCT01698944TerminatedPhase 4

Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency

Novo Nordisk A/S1 site in 1 country7 target enrollmentStarted: May 16, 2001Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
7
Locations
1
Primary Endpoint
Left Ventricular systolic function
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Somatropin

Experimental

Intervention: somatropin (Drug)

Outcomes

Primary Outcomes

Left Ventricular systolic function

Left Ventricular diastolic function

Secondary Outcomes

  • Body composition
  • Oral glucose tolerance test (OGTT)
  • Fasting glucose
  • HbA1c (glycosylated haemoglobin)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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