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Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency

This study has been terminated.
(The trial was prematurely terminated due to low recruitment)
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01698944
First received: October 1, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Growth Hormone Disorder
Adult Growth Hormone Deficiency
 Drug: somatropin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Left Ventricular systolic function [ Designated as safety issue: No ]
  • Left Ventricular diastolic function [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Designated as safety issue: No ]
  • Fasting glucose [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Oral glucose tolerance test (OGTT) [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: May 2001
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Somatropin Drug: somatropin
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

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698944

Locations
Greece
Athens, Greece, GR-11527
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: V. Fragoulopoulos, MD Novo Nordisk Hellas Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01698944     History of Changes
Other Study ID Numbers: GHDADULT-1112
Study First Received: October 1, 2012
Last Updated: October 3, 2012
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013