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

PHASE3CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

March 10, 2010

Primary Completion Date

July 12, 2012

Study Completion Date

December 21, 2012

Conditions
Hyperparathyroidism, PrimaryHypercalcemia
Interventions
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.

Trial Locations (47)

1083

Research Site, Budapest

1088

Research Site, Budapest

1113

Research Site, Budapest

2031

Research Site, Randwick

2065

Research Site, St Leonards

3011

Research Site, Footscray

3220

Research Site, Geelong

6009

Research Site, Nedlands

6720

Research Site, Szeged

10032

Research Site, New York

20010

Research Site, Washington D.C.

28557

Research Site, Morehead City

30322

Research Site, Atlanta

32204

Research Site, Jacksonville

33028

Research Site, Pembroke Pines

33145

Research Site, Miami

33180

Research Site, Aventura

33331

Research Site, Weston

33756

Research Site, Clearwater

46202

Research Site, Indianapolis

48236

Research Site, Detroit

70065

Research Site, Kenner

70121

Research Site, New Orleans

80045

Research Site, Aurora

92124

Research Site, San Diego

92630

Research Site, Lake Forest

92691

Research Site, Mission Viejo

92869

Research Site, Orange

93534

Research Site, Lancaster

95032

Research Site, Los Gatos

117036

Research Site, Moscow

119034

Research Site, Moscow

129110

Research Site, Moscow

150003

Research Site, Yaroslavl

197341

Research Site, Saint Petersburg

344022

Research Site, Rostov-na-Dony

43210-1296

Research Site, Columbus

T2N 4Z6

Research Site, Calgary

N6A 4V2

Research Site, London

L6J 1X8

Research Site, Oakville

M5C 2T2

Research Site, Toronto

01-809

Research Site, Warsaw

02-097

Research Site, Warsaw

02-507

Research Site, Warsaw

3000-075

Research Site, Coimbra

1350-179

Research Site, Lisbon

1649-035

Research Site, Lisbon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY