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AMG 073

Phase 3

Secondary Hyperparathyroidism | Small molecule | Endocrine |Amgen Inc.|Last Updated: May 8, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment780
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00042653A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on DialysisPHASE3 COMPLETED 380 — — May 1, 2002Jul 1, 2003May 8, 2013 - —
NCT00037635A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis PatientsPHASE3 COMPLETED 400 — — Dec 1, 2001Mar 1, 2003May 8, 2013 - —
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Study Endpoints
Primary Endpoints
To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.
Efficacy Assessment phase - final 10 weeks of study
Secondary Endpoints
To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase
Efficacy Assessment phase - final 10 weeks of study
To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase
Efficacy Assessment phase - final 10 weeks of study
To evaluate the safety of AMG 073 compared with placebo
Entire study - 26 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AMG 073EXPERIMENTALAMG 073
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
PlaceboDRUG30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally
AMG 073DRUG30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.

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