Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT01538966
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed patients with acromegaly who have not had surgery or medical therapy
* Acromegaly patients who are at least 3 months post surgery, who are/are not receiving adjuvant medical therapy
* Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels
* Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.
* Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist.
* Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant (daily or weekly
* Normal liver function tests before randomization to treatment
* The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy.
Exclusion Criteria:
* The patient harbors a macroadenoma with visual field defects due to chiasmatic compression
* The patient has clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit of normal at the baseline visit.
* The patient had pituitary surgery within 3 months prior to study entry
* The patient had radiotherapy within 12 months prior to study entry
* The patient has abnormal CBC and chemistry panel at the baseline visit, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety.
* The patient has a known hypersensitivity to any of the test materials or related compounds.
* The patient has a history of, or known current problems with alcohol or drug abuse.
* The patient has any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01538966
Study Brief:
Protocol Section:
NCT01538966