A multicenter, randomized, blinded study to assess the safety and efficacy of pasireotide LAR vs. octreotide LAR in patients with active acromegaly
- Conditions
- Acromegaly is characterized by chronic hypersecretion of growth hormone (GH), clinical features comprise structural and functional changes occurring in practically all organs. Cardiovascular disease is the main reason for morbidity and increased mortality.MedDRA version: 9.1Level: LLTClassification code 10000599Term: Acromegaly
- Registration Number
- EUCTR2007-001972-36-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
1. Male or female patients of at least 18 years of age
2. Patients with active acromegaly demonstrated by
•a lack of suppression of GH nadir to < 1 µg/L after an oral tolerance test with 75 g of glucose (OGTT) (not applicable for diabetic patients) or a mean GH concentration of a 5-point profile within a 2 hour time period of > 5 µg/L
•elevated circulating IGF-1 concentration (age and sex adjusted)
3. a) Patients who have undergone one or more pituitary surgeries, but have not been treated medically or b) de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
4. Patients with a known history or new diagnosis of impaired fasting glucose or diabetes mellitus may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary
5. Patients for whom written informed consent to participate in the study has been obtained prior to any study felated activity
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients who are being or were treated with octreotide, lanreotide or dopamine agonists with the exception of a single dose of short-acting octreotide or short-acting dopamine agonists. In case of a single dose of short-acting octreotide, the dose should not be used to predict the response to the octreotide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomisation.
2. Patients who are being or were treated with GH antagonists
3. De-novo patients not having a visible pituitary adenoma on MRI
4. Patients who have received pasireotide (SOM230) prior to randomization
5. Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
6. Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
7. Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks of visit 1
8. Patients who have received radiotherapy (except for pituitary irradiation) for any reason in the 4 weeks prior to visit 1 must have recovered from any side effect of radiotherapy
9. Patients who have received pituitary irradiation within the last ten years prior to visit 1
10. Patients who are hypothyroid and not adequately treated with stable doses of thyroid hormone replacement therapy
11. Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by HbA1C >8%
12. Patients with symptomatic cholelithiasis
13. Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated partial thromboplastin time)
14. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
15. Patients with risk factors for torsades de pointes, i.e. patients with a baseline QTc >450 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, or patients receiving a concomitant medication known to prolong QT interval
16. Patients with confirmed central hypothyroidism, central hypoadrenalism and diabetes insipidus, unless they are adequately treated with stable doses of hormone replacement therapy for a minimum of three months prior to study entry (first dose of study medication). Patients with confirmed hypogonadism unless they are adequately treated with stable doses of HRT for a minimum of 3 months prior to study entry (first dose of study medication) except in case where HRT is not indicated
17. Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or patients with ALT and/or AST more than 2 x ULN, serum creatinine > 2.0 x ULN, serum bilirubin > 2 x ULN, serum albumin < 0.67 x LLN
18. Patients with WBC <3 x 109/L; Hgb <90% LLN; PLT <100 x 109/L
19. Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor’s Medical Monitor
20. Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female p
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method