AcromegalyPhase 4NCT00068042
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
A Phase 4 study testing Pegvisomant and Sandostatin LAR in people with Acromegaly, run by Pfizer at 55 sites in 13 countries.
Trial summary
The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Pegvisomant and Sandostatin LAR
- How many people
- 100 participants
- Where
- 55 sitesin 13 countries
- Study dates
- Apr 2003to May 2006
- Phase
- Phase 4
- 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
- Diagnosis of acromegaly
- IGF-I levels >=1.3xULN (upper limit of normal) at screening
- No history of radiotherapy or prior treatment with other drugs for acromegaly
- Minimum of two months must have elapsed post surgery prior to screening
Who cannot join
- Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
- AST/ALT >= 3xULN (upper limit of normal)
- Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
- Visual field defects (except post surgical stable residual defects)
- Unable to self administer drug
Trial locations and contacts
55 sites in 13 countries.
55 sites in 13 countries
United States13 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0030
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0108
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7600
Pfizer Investigational Site
Charlottesville, Virginia, 22908
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Chicago, Illinois
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15212
Pfizer Investigational Site
Portland, Oregon, 97239
Germany6 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Essen, 45147
Pfizer Investigational Site
Hamburg, 22767
Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Marburg, 35043
Italy5 sites
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Milan, 20122
Pfizer Investigational Site
Naples
Pfizer Investigational Site
Roma, 00168
Pfizer Investigational Site
Torino
Australia4 sites
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010
Pfizer Investigational Site
Fitzroy, Victoria, 3165
Pfizer Investigational Site
Heidelberg, Victoria, 3084
Pfizer Investigational Site
Westmead, New South Wales, 2145
Brazil4 sites
Pfizer Investigational Site
Curitiba, Paraná, 80030-110
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-003
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-590
Pfizer Investigational Site
São Paulo, São Paulo, 05403-060
Canada4 sites
Pfizer Investigational Site
Edmonton, Alberta, T6G 2S2
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Montreal, Quebec, H2L 2W5
Spain4 sites
Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08906
Pfizer Investigational Site
Madrid, Madrid, 28035
Pfizer Investigational Site
Seville, Sevilla, 41013
Sweden4 sites
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Stockholm, 171 76
Pfizer Investigational Site
Uppsala, 751 85
United Kingdom4 sites
Pfizer Investigational Site
Belfast, Ireland, BT12 6BA
Pfizer Investigational Site
Leeds, LS1 3EX
Pfizer Investigational Site
London, EC1A 7BE
Pfizer Investigational Site
London, SE1 7EH
France2 sites
Pfizer Investigational Site
Le Kremlin-Bicêtre, 94275
Pfizer Investigational Site
Pessac, 33604
Greece2 sites
Pfizer Investigational Site
Athens, Attika/Greece, 10676
Pfizer Investigational Site
Piraeus, 18537
Ireland2 sites
Pfizer Investigational Site
Cork
Pfizer Investigational Site
Dublin
About this study
The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.
- Conditions
- Acromegaly
- Being tested
- Pegvisomant, Sandostatin LAR
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegvisomantDrug
Sandostatin LARDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
Secondary outcomes (1)
The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2003 (estimated)
- Study startApr 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068042
- Sponsor's protocol ID
- PEGA-0435-003
- Other IDs
- A6291004
- Status last verified
- Apr 2008
- First submitted
- 4 Sep 2003
- Last updated
- 7 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
- ClinicalTrials.gov ID
- NCT00068042
- Acronym / sponsor ID
- PEGA-0435-003
- Conditions
- Acromegaly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- May 2006 (actual)
- First posted
- 8 Sep 2003 (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 purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of acromegaly
- IGF-I levels >=1.3xULN (upper limit of normal) at screening
- No history of radiotherapy or prior treatment with other drugs for acromegaly
- Minimum of two months must have elapsed post surgery prior to screening
Key exclusion criteria (5 listed)
- Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
- AST/ALT >= 3xULN (upper limit of normal)
- Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
- Visual field defects (except post surgical stable residual defects)
- Unable to self administer drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegvisomant | Drug | – |
| Sandostatin LAR | Drug | – |
Primary outcome
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
1 secondary outcome
The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit
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 7 Apr 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Acromegaly
RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
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.
Pfizer CT.gov Call Center study director
Pfizer
55 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegvisomant and Sandostatin LAR in people with Acromegaly, run by Pfizer at 55 sites in 13 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 5 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 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Germany, Italy, Australia, Brazil and 8 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2008.