Clinical trials: sponsored by Amgen
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol…
- Trial name
- GAUSS-2 (NCT01763905)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 12 more
- Volunteers
- 307 people
- Sponsor
- Amgen
Multiple Myeloma
Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
The primary objectives are: Phase 1b: To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oprozomib given orally, once daily, on 2 different schedules.
- Trial name
- NCT01832727
- Testing
- Oprozomib, Dexamethasone
- Where
- 13 sites in United States, France
- Volunteers
- 65 people
- Sponsor
- Amgen
Advanced Renal Cell Carcinoma
AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib
This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.
- Trial name
- NCT00853372
- Testing
- Sunitinib, Trebananib
- Volunteers
- 85 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
- Trial name
- NCT02341417
- Testing
- Cinacalcet
- Where
- 33 sites in United States, Belgium and 9 more
- Volunteers
- 28 people
- Sponsor
- Amgen
Chronic Kidney Disease, Secondary Hyperparathyroidism
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
- Trial name
- NCT02138838
- Testing
- Cinacalcet HCl, Standard of Care
- Where
- 60 sites in United States, Belgium and 14 more
- Volunteers
- 55 people
- Sponsor
- Amgen
Chronic Kidney Disease, Hyperparathyroidism
Pediatric Chronic Kidney Disease Safety and Efficacy
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not…
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary, Kidney Disease
- Trial name
- NCT01277510
- Testing
- cinacalcet capsule, Standard of Care
- Where
- 51 sites in United States, Australia and 8 more
- Volunteers
- 43 people
- Sponsor
- Amgen
Cutaneous Lupus Erythematosus
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
- Trial name
- NCT01300208
- Testing
- CC-11050
- Where
- 19 sites in United States
- Volunteers
- 48 people
- Sponsor
- Amgen
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole
This is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects.
- Trial name
- NCT04139226
- Testing
- CC-11050
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Amgen
Psoriatic Arthritis
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen…
- Trial name
- PALACE-1 (NCT01172938)
- Testing
- Apremilast 20mg, Apremilast 30mg
- Where
- 92 sites in United States, Australia and 11 more
- Volunteers
- 504 people
- Sponsor
- Amgen
Behcet Syndrome
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.
- Trial name
- NCT00866359
- Testing
- Apremilast (CC-10004)
- Where
- 7 sites in United States, Turkey (Türkiye)
- Volunteers
- 111 people
- Sponsor
- Amgen
Psoriatic Arthritis
Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis
This study is to look at the preliminary efficacy and safety of 2 dose regimens of apremilast (20 mg twice a day and 40 mg once a day) versus placebo in patients with active psoriatic arthritis.
- Trial name
- NCT00456092
- Testing
- Apremilast
- Where
- 38 sites in Belgium, Canada and 3 more
- Volunteers
- 204 people
- Sponsor
- Amgen
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
- Trial name
- NCT01290029
- Testing
- Cinacalcet
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Amgen
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
- Trial name
- NCT01439867
- Testing
- Cinacalcet hydrochloride, Standard of Care
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 18 people
- Sponsor
- Amgen
Plaque Psoriasis
Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).
- Trial name
- NCT02749370
- Testing
- Etanercept
- Where
- 22 sites in United States
- Volunteers
- 80 people
- Sponsor
- Amgen
Psoriasis
A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.
- Trial name
- STYLE (NCT03123471)
- Testing
- Apremilast
- Where
- 45 sites in United States, Canada
- Volunteers
- 303 people
- Sponsor
- Amgen
Psoriatic Arthritis
Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis
The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.
- Trial name
- NCT01925768
- Testing
- Apremilast 30 mg
- Where
- 71 sites in United States, Australia and 8 more
- Volunteers
- 219 people
- Sponsor
- Amgen
Ankylosing Spondyloarthritis
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines.
- Trial name
- POSTURE (NCT01583374)
- Testing
- Apremilast tablet 20 mg, Apremilast tablet 30 mg BID
- Where
- 103 sites in United States, Australia and 16 more
- Volunteers
- 490 people
- Sponsor
- Amgen
Rheumatoid Arthritis
Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis
The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen…
- Trial name
- NCT01285310
- Testing
- Apremilast 30 mg, Apremilast 20 mg
- Where
- 50 sites in United States, Czechia and 2 more
- Volunteers
- 237 people
- Sponsor
- Amgen
Dermatitis, Atopic Dermatitis
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis
- Trial name
- NCT02087943
- Testing
- Apremilast
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 191 people
- Sponsor
- Amgen
Psoriasis, Psoriatic Arthritis
Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.
- Conditions
- Psoriasis, Psoriatic Arthritis, Psoriasis Arthropatica
- Trial name
- NCT01988103
- Testing
- Apremilast
- Where
- 56 sites in Japan
- Volunteers
- 254 people
- Sponsor
- Amgen
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