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Trial · Interventional

CompletedPhase 4Registry data

A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

NCTNCT00068042 (opens ClinicalTrials.gov in a new tab)Other idPEGA-0435-003Other idA6291004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
100 participants
Sponsor
Pfizer · Industry
Design
Randomized · Open label (no masking)
Countries
13 countries

United States, Australia, Brazil, Canada, France, Germany, Greece, Ireland, Italy, Norway, Spain, Sweden, United Kingdom

Start
Apr 2003
Primary completion
Not stated
Completion
May 2006
First posted
8 Sept 2003 (estimated)
Last update posted
7 Apr 2008 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20032004200520062007
  1. Ph 4

    A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

    NCT00068042

    Apr 2003 to May 2006

Registry summary

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

The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.

Interventions

  • PegvisomantDrug
  • Sandostatin LARDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)

Secondary outcomes(1)

  1. The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit

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
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of acromegaly * IGF-I levels \>=1.3xULN (upper limit of normal) at screening * No history of radiotherapy or prior treatment with other drugs for acromegaly * Minimum of two months must have elapsed post surgery prior to screening Exclusion Criteria: * Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations * AST/ALT \>= 3xULN (upper limit of normal) * Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI * Visual field defects (except post surgical stable residual defects) * Unable to self administer drug

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