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Trial · Interventional

CompletedPhase 4Registry data

Pegvisomant And Sandostatin LAR Combination Study

NCTNCT00068029 (opens ClinicalTrials.gov in a new tab)Other idPEGA-0435-005Other idA6291006
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Netherlands, Norway, Spain, United Kingdom

Start
Oct 2003
Primary completion
Not stated
Completion
May 2006
First posted
5 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

    Pegvisomant And Sandostatin LAR Combination Study

    NCT00068029

    Oct 2003 to May 2006

Registry summary

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

The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.

Interventions

  • Pegvisomant/ Sandostatin LARDrug
  • Sandostatin LARDrug
  • PegvisomantDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of subjects experiencing treatment-emergent adverse events across the duration fo the study

Secondary outcomes(1)

  1. Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific

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 * Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment * Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment Exclusion Criteria: * Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations * Patients on current medical therapy other than Sandostatin LAR * AST/ALT \>= 3xULN (upper limits 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 * Radiotherapy within 12 months of entering the study

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