A single-dose study to assess the safety and the manner in which the body metabolizes (breaks down) and gets rid of cinacalcet HCl, specifically in children with kidney failure who are being treated with dialysis • To evaluate the safety and tolerability of cinacalcet HCl after single administration to pediatric patients aged 28 days to < 6 years with CKD receiving dialysis

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An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects with Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone Primary Objectives: To evaluate response to treatment of denosumab in subjects with recurrent or unresectable GCT. Response is defined as: • elimination of giant cells, or doubling of the percentage ...

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Study to assess the tolerability and efficacy of AMG 145 co-administered with statins in patients with hypercholesterolemia To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every 2 weeks (Q2W) or every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholestero...

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A phase 2 biomarker study evaluating subjects with unresected, advanced melanoma treated with talimogene laherparepvec To explore the correlation between a baseline immunoprofile (ie, intratumoral CD8+ cell density) and objective response rate (ORR) in subjects with unresected stage IIIB to IVM1c melanoma treated with...

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A Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events when AMG 145 is used in combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease To evaluate the effect of treatment with AMG 145, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascula...

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Ensayo aleatorizado de fase 2 de quimiorradioterapia con o sin Panitumumab en sujetos con carcinoma de células escamosas de cabeza y cuello localmente avanzado y no resecado Determinar, con una precisión preespecificada, la diferencia en la tasa de control locorregional (CLR) a los 2 años en sujetos que reciben panitumumab más quimiorradioterapia (PQRT) o solamente quimio...

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A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects with Secondary Hyperparathyroidism Not Receiving Dialysis To evaluate the efficacy of cinacalcet compared with placebo by determining the proportion of subjects achieving a mean reduction of ≥ 30% in intact parathyroid hormone (iPTH) during the efficacy asse...

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Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Estudio para evaluar la eficacia, seguridad y farmacocinética de denosumab en niños con osteogénesis imperfecta To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score at 12 months, as assessed by dual-energy X-ray absorptiometry (DXA), in children 2 to 17 years of age with osteog...

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An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MDS) The primary objective is to provide long-term safety data for the use of romiplostim in thrombocytopenic subjects with myelodysplastic syndromes (MDS).

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Open label extension study to assess long-tem safety and efficacy of Evolocumab (AMG 145) To characterize the safety and tolerability of long-term administration of AMG 145

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