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A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00234520
First received: October 5, 2005
Last updated: June 26, 2008
Last verified: June 2008
History of Changes
  Purpose

The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide


Condition Phase
Acromegaly
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months

Secondary Outcome Measures:
  • Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
  • Risk in each of the 4 valves at 6 & 12 months
  • Risk of significant regurgitation in each valve at 6 & 12 months
  • Prevalence of valvular regurgitation at baseline
  • Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months

Estimated Enrollment: 200
Study Start Date: May 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234520

  Show 33 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: France Catus, MD Ipsen
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00234520     History of Changes
Other Study ID Numbers: 2-47-52030-721
Study First Received: October 5, 2005
Last Updated: June 26, 2008
Health Authority: United States: Food and Drug Administration
Belgium: Directorate general for the protection of Public health: Medicines
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Spain: Ministry of Health
Sweden: Medical Products Agency
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Endocrine System Diseases
Octreotide
Lanreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013