AcromegalyNCT00234520
A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide
An observational study of Acromegaly, run by Ipsen at 33 sites in 10 countries.
Trial summary
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 225 participants
- Where
- 33 sitesin 10 countries
- Study dates
- May 2003to 18 Feb 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 10 countries.
33 sites in 10 countries
France7 sites
Hôpital de Bois
Bois-Guillaume, 76233
Hôpital de la Timone
Marseille, 43385
CHU de Brabois
Nancy, 54511
Centre Hospitalier Régional d'Orléans
Orléans, 45067
Hôpital du Haut-Lévêque
Pessac, 33604
Hôpital Maison Blanche
Reims, 51092
CHU de Rangueil
Toulouse, 31054
Italy6 sites
Ospedali Riuniti di Bergamo
Bergamo, 24128
Università degli Studi di Ferrara
Ferrara, 20122
Dipartimento di Scienze, Endocrinologiche e Metaboliche
Genova, 46100
Università degli Studi di Milano
Milan, 20122
University "Federico II" of Naples
Naples, 80131
Clinica Medica II
Roma, 00161
United Kingdom5 sites
Queen Elizabeth Medical Centre
Edgbaston, Birmingham, B15 2TH
Royal Free Hospital
Hampstead, NW3 2QG
Michael White Diabetes Centre
Hull, HU3 2RW
Christie Hospital
Manchester, M20 4BX
Northern General Hospital
Sheffield, S5 7AU
Belgium3 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
UZ Gasthuisberg
Leuven, 3000
CHU de Liege
Liège, 44000
Spain3 sites
Hospital General de Alicante
Alicante, 03012
Clínica Puerta de Hierro
Madrid, 28035
Fundación Jiménez Díaz
Madrid, 28040
Sweden3 sites
Research Centre for Endocrinology and Metabolism
Gothenburg, 41345
Endokrinologiska kliniken
Malmö, 20502
Karolinska Sjukhuset
Stockholm, 17176
Czechia2 sites
University Hospital, Charles University
Kralove, 50005
1st School of Medicine, Charles University
Prague, 12000
Hungary2 sites
Semmelweis University Medical School
Budapest, 1088
National Medical Center
Budapest, 1135
About this study
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
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startMay 2003
- Primary completion18 Feb 2005
- Study completion18 Feb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234520
- Sponsor's protocol ID
- 2-47-52030-721
- Status last verified
- Aug 2019
- First submitted
- 5 Oct 2005
- Last updated
- 2 Aug 2019
- Results posted
- No
Publications
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.
PubMed 18381583
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00234520
- Acronym / sponsor ID
- 2-47-52030-721
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- 18 Feb 2005 (actual)
- Study completion
- 18 Feb 2005 (actual)
- First posted
- 7 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Results publication: PubMed 18381583Colao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
33 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Ipsen at 33 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France, Italy, United Kingdom, Belgium, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.