A multicenter, randomized, blinded study to assess safety and efficacy of pasireotide LAR vs. octreotide LAR in patients with active acromegaly - ND

• Conditions: ACROMEGALY; MedDRA version: 9.1Level: LLTClassification code 10000599Term: Acromegaly

• Registration Number: EUCTR2007-001972-36-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-15
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Male or female patients aged between 18 and 80 years. 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) or a mean GH concentration of a 5-point profile within a 2 hour time period of > 5 μg/L an elevated circulating IGF-1 concentration (age and sex adjusted) Patients who are medical treatment naïve after first surgery, or de-novo patients who present with a visual adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is not indicated Patients with a known history 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 Patients for whom written informed consent to participate in the study has been obtained prior to any study related 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

Exclusion Criteria

Patients who are being or were treated with octreotide, lanreotide or dopamine agonists and patients who are currently treated with GH antagonists De-novo patients not having an adenoma visible on MRI Patients who have received pasireotide (SOM230) prior to randomization Patients with compression of the optic chiasm causing any visual field defect Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks of visit 1 Patients who have received radiotherapy (except pituitary irradiation) for any reason within 4 weeks of visit 1 must have recovered from any side effect of radiotherapy Patients who have received pituitary irradiation within the last two years prior to visit 1 Patients who are not biochemically euthyroid Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by HbA1C >8% Patients with symptomatic cholelithiasis 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, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment 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, and taking concomitant medications known to prolong QT interval 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 Patients with WBC <3 x 109/L; Hgb <13 g/dL for males and <12 g/dL for females; PLT <100 x 109/L 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 Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception with condoms. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study and for 3 months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs) History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to first dosing Known hypersensitivity to somatostatin analogues or any other component of the pasireotide

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified