NCT00975221

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Hyperparathyroidism, Primary
• Hypercalcemia

Interventions

Type	Name	Description
DRUG	Cinacalcet	Administered orally at a starting dose of 30 mg twice a day (BID). Participants will be eligible for a dose titration once every 3 weeks during the placebo-controlled dose titration phase based on corrected total serum calcium concentration and safety assessments obtained the previous week. Doses may be sequentially increased to 60 mg BID, 90 mg BID, and 90 mg 3 times a day (TID).
DRUG	Placebo	Administered orally following the same tiitration regimen as the experimental arm.

Timeline

• Start date: 2010-03-10
• Primary completion: 2012-07-12
• Completion: 2012-12-21
• First posted: 2009-09-11
• Last updated: 2018-10-17
• Results posted: 2016-01-25

Locations

47 sites across 7 countries: United States, Australia, Canada, Hungary, Poland, Portugal, Russia