Adult patients 18 to 80 years of age with diagnosed acromegaly eligible for treatment with a somatostatin analogue and not on previous pharmacological treatment for acromegaly.
Conditions
Interventions
Product Name: PASIREOTIDE
Product Code: SOM230
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Pasireotide
Current Sponsor code: SOM230
Concentration unit: IU
Sponsors
Göteborgs Universitet, Göteborg Sweden
Eligibility
Sex/Gender
All
Inclusion criteria
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 1.3 ULN (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 glucose metabolism may be included, however blood glucose and anti-diabetic 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Previous pharmacological treatment for acromegaly • Uncontrolled hypertension, treated or not treated, with a diastolic blood pressure >105 mm Hg. • Uncontrolled diabetes mellitus as evidenced by HbA1c>8% • Severe liver disease (ASAT/ALAT three times upper limit of normal range laboratory values • Severely reduced renal function (S-creatinine >250µmol/L) or suspected renal artery stenosis. • QTcF at screening > 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 hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block. • Concomitant disease(s) that could prolong QT 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. • Uncontrolled endocrine disorders • Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy • History of or ongoing malignancy • Patients in a catabolic state • Known drug and/or alcohol abuse • Inability to cooperate or administer study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of pasireotide Long Acting Release (LAR )on Left Ventricle M measured with CMR at 6 months.;Secondary Objective: To assess the efficacy of pasireotide LAR on LVM after 3 months. Cardiac geometry, systolic function including ejection fraction and end-systolic volume measured with CMR after 3 and 6 months and diastolic function, including diastolic transmitral peak velocities, the E/A ratio, the isovolumic relaxation time, and mitral deceleration time measured with echocardiography after 3 and 6 months. Quantitative diastolic data will be derived from tissue Doppler imaging (TDI) analysis. Lipid profile, mean of 5 serum GH samples collected within 2 hours after one hour resting, serum IGF-I, serum IGFBP-3, glucose/insulin ratio and blood pressure measured after 3 months and after 6 months. We propose that CMR data will be assessed centrally and that IGF-I and GH will be analysed in a central lab.;Primary end point(s): The effect of pasireotide on LVM after 6 months measured with CMR at 6 months. | — |
Countries
Italy, Netherlands, Sweden
Contacts
Public ContactPasireotide/Akromegaly Study
Göteborgs Universitet, Göteborg Sweden
Outcome results
None listed