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

NCT ID: NCT00234520

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-02-18

Brief Summary

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

Detailed Description

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Conditions

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Acromegaly

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Cliniques Universitaires Saint Luc

Brussels, , Belgium

Site Status

UZ Gasthuisberg

Leuven, , Belgium

Site Status

CHU de Liege

Liège, , Belgium

Site Status

University Hospital, Charles University

Kralove, , Czechia

Site Status

1st School of Medicine, Charles University

Prague, , Czechia

Site Status

National University Hospital

Copenhagen, , Denmark

Site Status

Hôpital de Bois

Bois-Guillaume, , France

Site Status

Hôpital de la Timone

Marseille, , France

Site Status

CHU de Brabois

Nancy, , France

Site Status

Centre Hospitalier Régional d'Orléans

Orléans, , France

Site Status

Hôpital du Haut-Lévêque

Pessac, , France

Site Status

Hôpital Maison Blanche

Reims, , France

Site Status

CHU de Rangueil

Toulouse, , France

Site Status

Semmelweis University Medical School

Budapest, , Hungary

Site Status

National Medical Center

Budapest, , Hungary

Site Status

Ospedali Riuniti di Bergamo

Bergamo, , Italy

Site Status

Università degli Studi di Ferrara

Ferrara, , Italy

Site Status

Dipartimento di Scienze, Endocrinologiche e Metaboliche

Genova, , Italy

Site Status

Università degli Studi di Milano

Milan, , Italy

Site Status

University "Federico II" of Naples

Naples, , Italy

Site Status

Clinica Medica II

Roma, , Italy

Site Status

Bielanski Hospital

Warsaw, , Poland

Site Status

Hospital General de Alicante

Alicante, , Spain

Site Status

Clínica Puerta de Hierro

Madrid, , Spain

Site Status

Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Research Centre for Endocrinology and Metabolism

Gothenburg, , Sweden

Site Status

Endokrinologiska kliniken

Malmo, , Sweden

Site Status

Karolinska Sjukhuset

Stockholm, , Sweden

Site Status

Queen Elizabeth Medical Centre

Edgbaston, Birmingham, United Kingdom

Site Status

Royal Free Hospital

Hampstead, , United Kingdom

Site Status

Michael White Diabetes Centre

Hull, , United Kingdom

Site Status

Christie Hospital

Manchester, , United Kingdom

Site Status

Northern General Hospital

Sheffield, , United Kingdom

Site Status

Countries

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Belgium Czechia Denmark France Hungary Italy Poland Spain Sweden United Kingdom

References

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Colao A, Marek J, Goth MI, Caron P, Kuhn JM, Minuto FM, Weissman NJ. No greater incidence or worsening of cardiac valve regurgitation with somatostatin analog treatment of acromegaly. J Clin Endocrinol Metab. 2008 Jun;93(6):2243-8. doi: 10.1210/jc.2007-2199. Epub 2008 Apr 1.

Reference Type RESULT
PMID: 18381583 (View on PubMed)

Other Identifiers

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2-47-52030-721

Identifier Type: -

Identifier Source: org_study_id

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