Brief Title
A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide
Official Title
A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide
Brief Summary
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
Study Type
Observational
Primary Outcome
Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
Secondary Outcome
Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
Condition
Acromegaly
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
225
Start Date
May 2003
Completion Date
February 18, 2005
Primary Completion Date
February 18, 2005
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00234520
Organization ID
2-47-52030-721
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
August 2019