A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
NCT00068042
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly | |||
| Official Title ICMJE | A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Acromegaly | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 100 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | May 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Australia, Brazil, Canada, France, Germany, Greece, Ireland, Italy, Norway, Spain, Sweden, United Kingdom, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00068042 | |||
| Other Study ID Numbers ICMJE | PEGA-0435-003 A6291004 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||