Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01562834
First received: March 22, 2012
Last updated: June 28, 2012
Last verified: June 2012

March 22, 2012
June 28, 2012
October 1998
December 2002   (final data collection date for primary outcome measure)
Left ventricular mass measured with ultrasonography [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562834 on ClinicalTrials.gov Archive Site
  • Ventricular function indices assessed by cardiac ultrasonography [ Designated as safety issue: No ]
  • Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry) [ Designated as safety issue: No ]
  • Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales [ Designated as safety issue: No ]
  • IGF-I (Insulin-Like Growth Factor I) concentration [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients

This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
  • Drug: somatropin
    Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.
  • Drug: placebo
    Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.
  • Experimental: Somatropin
    Intervention: Drug: somatropin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
December 2002
December 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Childhood or adult onset growth hormone deficiency (GHD)
  • GHD evidenced by two stimulation tests
  • Duration of GHD at least 5 years
  • Other hormone deficiencies associated with growth hormone deficiency

Exclusion Criteria:

  • Pregnancy or pregnancy desired during the suggested duration of the study
  • Personal history of colonic polyp or family history of colonic polyposis
  • Known insulin-dependent or non-insulin-dependent diabetes
  • Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment
  • BMI (Body Mass Index) at least 30
  • Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy
  • Patient who has participated in a different clinical study within the past two months
  • Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study
  • Notion of breast cancer for the mother or the sister
Not Provided
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01562834
GHDADULT/F/1/F
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Catherine Boisson-Lesage, MD Novo Nordisk Pharmaceutique SAS
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP