Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion Criteria:

• Men and Women greater than or equal to 18 years of age

• Using effective contraceptive measures

• Mean iPTH during screening of greater than or equal to 300 pg/mL

• Mean calcium during screening of greater than or equal to 8.4 mg/dL

• Stable on hemodialysis

Exclusion Criteria:

• Unstable medical conditions

• Parathyroidectomy within 3 months

• Change in Vitamin D therapy

• Receiving antidepressants

• Experienced an MI within 3 months

• Inability to swallow tablets

• Previously received AMG 073