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

• Conditions: Reduction of hypercalcemia in subjects with primary hyperparathyroidism (HPT) who meet criteria for parathyroidectomy on the basis of corrected total serum calcium, but who are unable to undergo parathyroidectomy.; MedDRA version: 12.0Level: LLTClassification code 10036693Term: Primary hyperparathyroidism

• Registration Number: EUCTR2009-012943-41-PT
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-04
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to demonstrate the efficacy of cinacalcet for normalizing corrected total serum calcium in subjects with primary HPT who meet criteria for parathyroidectomy on the basis of corrected total serum calcium level, but who are unable to undergo parathyroidectomy;Secondary Objective: To demonstrate the efficacy of cinacalcet for reducing corrected total serum calcium levels<br>Safety Objective: to assess the safety and tolerability of cinacalcet.;Primary end point(s): achievement of a mean corrected total serum calcium concentration = 10.3 mg/dL (2.57 mmol/L) during the EAP (weeks 16, 20, 24, and 28)