Clinical trials: sponsored by Amgen
Osteoporosis
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.
- Trial name
- NCT03822078
- Testing
- Denosumab
- Volunteers
- 45 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with…
- Trial name
- NCT01896232
- Testing
- Etelcalcetide, Cinacalcet
- Where
- 182 sites in United States, Austria and 20 more
- Volunteers
- 683 people
- Sponsor
- Amgen
Arthritis, Rheumatoid; Arthritis, Psoriatic
Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis
The primary objective was to assess the injection site pain associated with the new formulation of etanercept compared with commercial etanercept in adults with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) as measured…
- Trial name
- NCT02986139
- Testing
- Commercial Formulation Etanercept, New Formulation Etanercept
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 111 people
- Sponsor
- Amgen
Chronic Kidney Disease, Secondary Hyperparathyroidism
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
- Trial name
- NCT02833857
- Testing
- Etelcalcetide
- Where
- 13 sites in United States, Belgium and 4 more
- Volunteers
- 11 people
- Sponsor
- Amgen
Osteopenia
A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass
The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of…
- Trial name
- NCT00950950
- Testing
- Romosozumab
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteopenia
A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.
- Trial name
- NCT01059435
- Testing
- Romosozumab
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Amgen
Cardiovascular
AMG 529 First in Human Study
A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.
- Trial name
- NCT03170193
- Testing
- AMG 529
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Ulcerative Colitis
Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis
The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points…
- Trial name
- NCT01694485
- Testing
- Abrilumab
- Where
- 123 sites in United States, Australia and 18 more
- Volunteers
- 359 people
- Sponsor
- Amgen
Crohn's Disease
Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 weeks.
- Trial name
- NCT01696396
- Testing
- Abrilumab
- Where
- 84 sites in United States, Austria and 10 more
- Volunteers
- 254 people
- Sponsor
- Amgen
Hyperlipidemia
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein…
- Trial name
- RUTHERFORD-2 (NCT01763918)
- Testing
- Evolocumab
- Where
- 39 sites in United States, Australia and 12 more
- Volunteers
- 331 people
- Sponsor
- Amgen
Hyperlipidemia and Mixed Dyslipidemia
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
- Trial name
- OSLER-2 (NCT01854918)
- Testing
- Evolocumab, Standard of Care
- Where
- 363 sites in United States, Australia and 23 more
- Volunteers
- 3,681 people
- Sponsor
- Amgen
Migraine
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.
- Trial name
- NCT02542605
- Testing
- Erenumab, PACAP-38 Challenge Agent
- Where
- 3 sites in United States, Belgium and 1 more
- Volunteers
- 35 people
- Sponsor
- Amgen
Osteoporosis in Men
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine.
- Trial name
- BRIDGE (NCT02186171)
- Testing
- Romosozumab
- Where
- 34 sites in United States, Belgium and 8 more
- Volunteers
- 245 people
- Sponsor
- Amgen
Advanced Malignancy, Advanced Solid Tumors
A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors
This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK of oral AMG 900 in subjects…
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Cancer, Solid Tumors
- Trial name
- NCT00858377
- Testing
- Arm 1- Dose Escalation, Arm 1- Dose Expansion
- Where
- 8 sites in United States, Australia
- Volunteers
- 95 people
- Sponsor
- Amgen
Osteoporosis
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).
- Trial name
- NCT02576652
- Testing
- Tetracycline, Demeclocycline, Total Hip Replacement
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Amgen
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
- Trial name
- NCT01785875
- Testing
- Etelcalcetide
- Where
- 208 sites in United States, Australia and 15 more
- Volunteers
- 891 people
- Sponsor
- Amgen
Psoriasis
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
- Trial name
- NCT01970488
- Testing
- Adalimumab, ABP 501
- Where
- 3 sites in Australia, Canada and 1 more
- Volunteers
- 350 people
- Sponsor
- Amgen
Healthy Subjects
Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan
The primary objective of this study was to assess the effects of subcutaneous sumatriptan alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan concomitant therapy on resting blood pressure…
- Trial name
- NCT02741310
- Testing
- Sumatriptan, Erenumab
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteoporosis
Transition From Alendronate to Romosozumab (AMG 785)
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated…
- Trial name
- NCT01588509
- Testing
- Romosozumab
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis (PMO)
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.
- Trial name
- NCT01992159
- Testing
- Romosozumab
- Where
- 27 sites in Japan
- Volunteers
- 252 people
- Sponsor
- Amgen
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