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Clinical Trials/NCT01698944
NCT01698944
Terminated
Phase 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 enrollmentMay 16, 2001

Overview

Phase
Phase 4
Intervention
somatropin
Conditions
Growth Hormone Disorder
Sponsor
Novo Nordisk A/S
Enrollment
7
Locations
1
Primary Endpoint
Left Ventricular systolic function
Status
Terminated
Last Updated
9 years ago

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).

Registry
clinicaltrials.gov
Start Date
May 16, 2001
End Date
November 18, 2002
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Somatropin

Intervention: somatropin

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)

Study Sites (1)

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