Status:
COMPLETED
A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
Eligibility Criteria
Inclusion
- Patient has a diagnosis of Acromegaly
- Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline
- Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country
- Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study
Exclusion
- Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide
- Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months
- Patients who have received treatment with a GH antagonist for more than 3 months
- Patients who have had heart valve replacement therapy
Key Trial Info
Start Date :
May 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 18 2005
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00234520
Start Date
May 1 2003
End Date
February 18 2005
Last Update
August 2 2019
Active Locations (33)
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1
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
2
UZ Gasthuisberg
Leuven, Belgium, 3000
3
CHU de Liege
Liège, Belgium, 44000
4
University Hospital, Charles University
Kralove, Czechia, 50005