A phase III, multicenter, randomized, parallel-group study to assess the efficacy and safety of double-blind pasireotide LAR 40 mg and pasireotide LAR 60 mg versus open-label octreotide LAR or lanreotide ATG in patients with inadequately controlled 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: 14.1 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
- Registration Number
- EUCTR2009-016722-13-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 198
•Male and female patients = 18 years of age
•Patients with written informed consent prior to any study related activity
•Patients with inadequately controlled acromegaly as defined by
•a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L
and
•sex- and age adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
•Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to Visit 1 (Screening). The maximum indicated dose for octreotide LAR is 30 mg and for lanreotide ATG is 120 mg
•Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery
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
•Patients who have received pasireotide (SOM 230) prior to enrolment
•Concomitant treatment with GHR-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to Visit 1 (Screening) (8-week wash-out period)
•Patients with compression of the optic chiasm causing acute clinically significant visual field defects
•Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
•Patients who have received pituitary irradiation within 10 years prior to Visit 1 (Screening)
•Patients who have undergone major surgery/surgical therapy for
any cause within 4 weeks prior to Visit 1 (Screening)
•Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
•Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8% at Visit 1 (Screening). Patients with a known history of impaired fasting glucose or diabetes mellitus with HbA1c<8% may be included; however, blood glucose and anti diabetic treatment must be monitored closely throughout the trial and adjusted as necessary
• Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included)
•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)
•Patients who have congestive heart failure (NYHA Class III or
IV), unstable angina, sustained ventricular tachycardia,
ventricular fibrillation, advanced heart block or a history of acute myocardial infarction within the 6 months preceding Visit 1 (Screening)
•Screening or baseline (predose) QTcF > 450 msec
•History of syncope or family history of idiopathic sudden death
•Sustained or clinically significant cardiac arrhythmias
•Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia or high-grade AV block.
•Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson’s disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
•Concomitant medication(s) known to increase the QT interval
•Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B or C or chronic persistent hepatitis, or patients with ALT and/or AST more than 2 x ULN, total serum bilirubin > 1.5 x ULN, serum albumin < 0.67 x LLN
•Patients with serum creatinine > 2.0 x ULN
•Patients with WBC <3 x 109/L; Hgb < 90% LLN; PLT <100 x 109/L
•Patients with any current or prior medical condition that, in the judgment of the investigator may interfere with the conduct of the study or the evaluation of the study results
•History of immunocompromise, including a positive HIV test
result (ELISA and Western blot). A HIV test will not b
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