EUCTR2009-009502-79-IT进行中（未招募）不适用
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 - ipermen
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI0 个研究点开始时间: 2009年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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