open, non comparative, prospectic, phase IV clinical study to evaluate the activity and tolerance of Cinacalcet-HCl (drug name Mimpara) in patients affected by MEN1-associated primary hyperparathyroidism - iperme

Active, not recruiting

• Conditions: Primary hyperparathyroidism in patients with MEN1; MedDRA version: 12.0Level: LLTClassification code 10020707Term: Hyperparathyroidism primary

• Registration Number: EUCTR2009-009502-79-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-18
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Both genders and age >18 years 2. Serum levels of PTH and calcium above the upper limit of the range of reference 3rd Normal blood count and normal liver function (ALT, AST and alkaline phosphatase in normal range and total bilirubin <1.5 mg/ml) and renal (normal uremic levels and creatinine clearance> 50 ml/min) 4. Performance status <2 (ECOG) 5. Written informed consent 6. Female subjects treated with stable doses of SERMs or ERT will be eligible
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

1. Pregnancy (assessed by specific test) and lactation. The state of pregnancy during treatment involves the suspension of therapy and exit of patients from the study. 2. Creatinine clearance <50 ml/min (0.83 ml/sec) 3. Treatment with bisphosphonates or peptides of PTH, strontium ranelate or cinacalcet itself within 90 days before the baseline visit 4. Because cinacalcet inhibits cytochrome P450 2D6 (CYP2D6), we exclude patients requiring drugs that are metabolized by this enzyme and with a narrow therapeutic index, such as flecainide, thioridazine and many tricyclic antidepressants 5. Presence of insulinoma 6. Insulin dependent diabetes mellitus with poor metabolic compensation (HbA1c> 8% or <5%) 7. Any serious disease with concomitant risk of life, in particular cardiovascular diseases such as heart disease of any type, uncontrolled hypertension, inastable angina and severe coronary disease 8. Patients included in a clinical treatment protocols in the last 6 months 9. Known hypersensitivity to cinacalcet

Study & Design

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