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Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

NCT00133354 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2011-10-12

No results posted yet for this study

Summary

The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year trial.

Conditions

  • Hypopituitarism

Interventions

DRUG

Arimidex (Anastrozole)

Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.

DRUG

Placebo

Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.

DRUG

Growth Hormone

GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of \~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • EMD Serono

    collaborator INDUSTRY

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Nelly Mauras, MD · Nemours Children's Clinic

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2006-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133354 on ClinicalTrials.gov