Pegvisomant And Sandostatin LAR Combination Study
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00068029
First received: September 4, 2003
Last updated: April 3, 2008
Last verified: April 2008
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Purpose
The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: Pegvisomant/ Sandostatin LAR Drug: Sandostatin LAR Drug: Pegvisomant |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Secondary Outcome Measures:
- Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific
| Estimated Enrollment: | 75 |
| Study Start Date: | October 2003 |
| Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of acromegaly
- Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment
- Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment
Exclusion Criteria:
- Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
- Patients on current medical therapy other than Sandostatin LAR
- AST/ALT >= 3xULN (upper limits 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
- Radiotherapy within 12 months of entering the study
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068029
Show 33 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068029
Show 33 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00068029 History of Changes |
| Other Study ID Numbers: | PEGA-0435-005 A6291006 |
| Study First Received: | September 4, 2003 |
| Last Updated: | April 3, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Octreotide Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 28, 2016