ABOUT THIS STUDY
1. Acromegaly in adult subjects (≥ 18 years) either controlled or uncontrolled (Diagnosis should be based on OGTT where Acromegaly is defined as a lack of suppression of GH nadir to < 0.5 ng/dL, after oral administration of 75 g of glucose, OGTT and IGF-I levels at least 10 % above the normal value ± 2 SD).
2. Written informed consent
1. Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent
hepatitis, or persistent ALT, AST, alkaline phosphatase 3 x > upper limit of normal,
or total bilirubin 2 x > upper limit of normal.
2. Renal failure (GFR ≤ 30 ml/min)
3. Abnormal clinical laboratory values considered by the investigator to be clinically
significant and which could affect the interpretation of the study results.
4. History of malignancy of any organ system, treated or untreated, within the past 3
years whether or not there is evidence of local recurrence or metastases, with the
exception of localized basal cell carcinoma of the skin.
5. Suspected or known drug or alcohol abuse.
6. Any condition which in the opinion of the investigator makes the patient unsuitable
7. Participation in any other clinical trial with an investigational new drug.
8. Patients on longterm, continuous (more than 2 weeks/year) systemic therapy with
glucocorticosteroids with exception of a substitution of a pituitary lack of
ACTH/cortisol (e.g. patients with panhypopituitarism).
9. Instable heart insufficiency for example cardiomyopathy, congestive heart failure
(NYHA class III or IV), unstable angina, sustained ventricular tachycardia,
10. Type I diabetes according to the guidelines of the European Diabetes Society or
obvious other manifestations of other forms of diabetes (e.g. steroid diabetes).
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