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AMG 073

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment320

FDA Designations

No designations recorded

Clinical trial landscape

AMG 073 · 5 trials · 4 indications

Phase 3 3Phase 2 2
NCT00042653A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on DialysisSecondary Hyperparathyroidism
COMPLETED380 Analytics
NCT00527267Safety and Efficacy Study of AMG 073 in Hemodialysis SubjectsHyperparathyroidism
COMPLETED320 Analytics
NCT00037635A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis PatientsSecondary Hyperparathyroidism
COMPLETED400 Analytics
PHASE3COMPLETED
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis
Secondary Hyperparathyroidism
NCT00042653380
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PHASE3COMPLETED
Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects
Hyperparathyroidism
NCT00527267320
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PHASE3COMPLETED
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
Secondary Hyperparathyroidism
NCT00037635400
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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
Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
entire 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 to 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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Competitive Landscape -Hyperparathyroidism 3 trials

CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN2PHASE3Etelcalcetide
OPKO Health, Inc.OPK1PHASE2CTAP101
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Frequently asked questions about AMG 073

What is AMG 073 used for?

AMG 073 is an investigational small molecule being developed for secondary hyperparathyroidism in patients with end stage renal disease, as well as for hyperparathyroidism and renal osteodystrophy. It is being studied in dialysis patients and those with renal osteodystrophy.

Who makes AMG 073?

AMG 073 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is in clinical development for nephrology indications.

What phase is AMG 073 in?

AMG 073 is in Phase 2 clinical development. It has completed Phase 2 and Phase 3 trials, but it remains investigational and has not been approved by regulatory authorities.

What clinical trials is AMG 073 in?

AMG 073 has completed several clinical trials, including NCT00037635 and NCT00042653 for secondary hyperparathyroidism in dialysis patients, NCT00527085 for renal osteodystrophy, and NCT00527267 for hyperparathyroidism in hemodialysis subjects. All trials are completed.

Is AMG 073 the same as cinacalcet?

No, AMG 073 is not the same as cinacalcet. AMG 073 is an investigational drug being studied for secondary hyperparathyroidism and related conditions, while cinacalcet is a separate, approved medication for similar indications.