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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Disorder; Adult Growth Hormone Deficiency

Intervention: somatropin (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Catherine Boisson-Lesage, MD, Study Director, Affiliation: Novo Nordisk Pharmaceutique SAS


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Left ventricular mass measured with ultrasonography

Secondary outcome:

Ventricular function indices assessed by cardiac ultrasonography

Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)

Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales

IGF-I (Insulin-Like Growth Factor I) concentration


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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

Locations and Contacts

Paris 75571, France
Additional Information

Clinical Trials at Novo Nordisk

Starting date: October 1998
Last updated: June 28, 2012

Page last updated: August 23, 2015

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