NCT01698944

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2001

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2002

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

October 1, 2012

Last Update Submit

February 23, 2017

Conditions

Growth Hormone DisorderAdult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (2)

  • Left Ventricular systolic function

  • Left Ventricular diastolic function

Secondary Outcomes (4)

  • Body composition

  • Fasting glucose

  • HbA1c (glycosylated haemoglobin)

  • Oral glucose tolerance test (OGTT)

Study Arms (1)

Somatropin

EXPERIMENTAL
Drug: somatropin

Interventions

somatropinDRUG

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

Somatropin

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adult growth hormone deficiency
  • At least 2 years without growth hormone treatment

You may not qualify if:

  • Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Athens, GR-11527, Greece

Location

Related Links

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

May 16, 2001

Primary Completion

November 18, 2002

Study Completion

November 18, 2002

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

GR(1)