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

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00234520

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 IV

Drug Information available for: Octreotide Octreotide acetate Lanreotide acetate

Study Type:	Observational
Study Design:	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

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

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

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

France Catus, MD

Ipsen

More Information

Publications of Results:

Study ID Numbers:	2-47-52030-721
Study First Received:	October 5, 2005
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00234520
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 - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Octreotide
Angiopeptin

Brain Diseases
Bone Diseases
Lanreotide
Musculoskeletal Diseases
Endocrinopathy
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009