A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

Amgen Inc0 个研究点目标入组 160 人开始时间: 2009年12月4日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•age =18 years
•diagnosis of primary HPT based on local/historical lab data measurements of:
•- total corrected serum calcium >1 mg/dL (0.25 mmol/L) above the upper limit of normal and = 12.5 mg/dL (3.12 mmol/L) as determined on 2 separate occasions at least 7 days apart within the last 6 months
•- plasma PTH > upper limit of normal as determined on 2 separate occasions at least 7 days apart within the last 6 months
•subjects must have the following lab values obtained from the central lab during screening:
•- corrected total serum calcium > 11.3 mg/dL (2.82 mmol/L) and = 12.5 mg/dL (3.12 mmol/L)
•- plasma PTH > 72 pg/mL (7.6 pmol/L)
•not able to undergo parathyroidectomy for = 1 of the following reasons:
•- failed parathyroidectomy
•- comorbid conditions contraindicating parathyroidectomy
•- parathyroidectomy not considered appropriate by primary physician and subject
•before any study-specific procedure is performed, the appropriate written informed consent must be obtained
•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

•symptoms attributable to hypercalcemia, requiring immediate medical intervention, as judged by the investigator (including acute kidney stone, nausea and vomiting requiring intravenous hydration, confusion, lethargy, stupor, or coma)
•unstable medical condition, defined as having been hospitalized within 30 days before the date of informed consent, or otherwise unstable in the judgment of the investigator
•administration of drugs that increase serum calcium concentration, including but not limited to thiazide diuretics or lithium
•initiated bisphosphonate therapy or changed bisphosphonate dose within 12 weeks before the date of informed consent
•current administration of drugs for ventricular arrhythmia
•unable to provide informed consent, or is at risk for poor compliance with study procedures
•currently enrolled in another investigational device or drug study(s), or completed such study within 30 days before the date of informed consent
•known hypersensitivity to or unable to tolerate cinacalcet
•received treatment with cinacalcet within 14 days before the date of informed consent
•history of seizures or an adjustment of anti-seizure medication within 12 weeks before the date of informed consent
•family history or diagnosis of familial benign hypocalciuric hypercalcemia (FBHH)
•refused to use highly effective contraceptive measures (as determined by the investigator) throughout the study
•pregnant or breastfeeding

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