Clinical Trial: Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of Hypercalcemia in Subjects With Primary Hyperparathyroidi

Brief Summary: This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy.

Detailed Summary: The study will consist of a 30-day screening phase, a 12-week placebo-controlled dose-titration phase, and a 16-week placebo-controlled efficacy assessment phase (EAP). Participants who complete 28 weeks on study will continue into an open-label safety extension phase for 24 weeks of investigational cinacalcet treatment.
Sponsor: Amgen

Current Primary Outcome: Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP [ Time Frame: Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28) ]

Original Primary Outcome: to demonstratethe 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 parathyroidecto [ Time Frame: 1 year ]

Current Secondary Outcome:

  • Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP [ Time Frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28) ]
  • Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP [ Time Frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28) ]
  • Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP [ Time Frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28) ]


Original Secondary Outcome: to demonstrate the efficacy of cinacalcet for reducing corrected total serum calcium levels [ Time Frame: 1 year ]

Information By: Amgen

Dates:
Date Received: September 10, 2009
Date Started: March 2010
Date Completion:
Last Updated: February 2, 2016
Last Verified: January 2016