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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT01562834 (opens ClinicalTrials.gov in a new tab)Other idGHDADULT/F/1/F
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Overview

Status
Completed
Phase
Phase 4
Enrollment
22 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

France

Start
21 Oct 1998
Primary completion
1 Dec 2002
Completion
1 Dec 2002
First posted
26 Mar 2012 (estimated)
Last update posted
28 Feb 2024
Conditions
Growth Hormone Disorder · Adult Growth Hormone Deficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
199819992000200120022003
  1. Ph 4

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

    NCT01562834

    21 Oct 1998 to 1 Dec 2002

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • somatropinDrug
  • placeboDrug

Arms2

  • Experimental

    Somatropin

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Left ventricular mass measured with ultrasonography

Secondary outcomes(4)

  1. Ventricular function indices assessed by cardiac ultrasonography

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

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

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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