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Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

NCT00383708 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2022-09-27

Study results available
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Summary

The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

Conditions

Interventions

DRUG

lanreotide (Autogel formulation)

120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.

DRUG

Pegvisomant

Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00383708 on ClinicalTrials.gov