Clinical trials: sponsored by Amgen
Chronic Obstructive Pulmonary Disease
A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an…
- Trial name
- NCT00739648
- Testing
- MP-376
- Where
- 39 sites in United States
- Volunteers
- 322 people
- Sponsor
- Amgen
Cystinosis
Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every…
- Trial name
- NCT01197378
- Testing
- Cysteamine Bitartrate Delayed-release Capsules
- Where
- 10 sites in United States, France and 1 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Friedreich's Ataxia
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia
The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreich's Ataxia (FA) and to evaluate the…
- Trial name
- STEADFAST (NCT02415127)
- Testing
- Interferon γ-1b
- Where
- 4 sites in United States
- Volunteers
- 92 people
- Sponsor
- Amgen
Cystinosis
Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis
Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the…
- Trial name
- NCT01000961
- Testing
- Cystagon® (Cysteamine Bitartrate), Cysteamine Bitartrate Delayed-release Capsules (RP103)
- Where
- 8 sites in United States, France and 1 more
- Volunteers
- 43 people
- Sponsor
- Amgen
Cystinosis
Pilot Study of Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of RP103 Compared to Cystagon® in Patients With Cystinosis
Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the…
- Trial name
- NCT00872729
- Testing
- Cystagon®, RP103
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Amgen
Friedreich's Ataxia
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study
The purpose of this phase 3 multi-center, open-label extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.
- Trial name
- STEADFAST (NCT02593773)
- Testing
- Interferon γ-1b
- Where
- 4 sites in United States
- Volunteers
- 86 people
- Sponsor
- Amgen
Rheumatoid Arthritis
A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis
The overall objective of the study is to assess the effectiveness of switching from immediate-release prednisone (conventional) therapy to delayed-release prednisone (RAYOS) in patients with moderately to severely active…
- Trial name
- SUNRAY (NCT02287610)
- Testing
- RAYOS (delayed-release prednisone)
- Volunteers
- 75 people
- Sponsor
- Amgen
Rheumatoid Arthritis
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD)…
- Trial name
- CAPRA-2 (NCT00650078)
- Testing
- MR prednisone
- Where
- 52 sites in United States, Canada and 4 more
- Volunteers
- 350 people
- Sponsor
- Amgen
Osteoarthritis, Rheumatoid Arthritis
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome
- Trial name
- NCT00984815
- Testing
- HZT-501
- Where
- 4 sites in United States
- Volunteers
- 86 people
- Sponsor
- Amgen
Cystic Fibrosis
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT01180634
- Testing
- Aeroquin
- Where
- 112 sites in United States, Australia and 3 more
- Volunteers
- 330 people
- Sponsor
- Amgen
Osteoarthritis, Rheumatoid Arthritis
Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome
- Trial name
- HZ-CA-304 (NCT00613106)
- Testing
- HZT-501, Ibuprofen
- Where
- United States
- Volunteers
- 179 people
- Sponsor
- Amgen
Asthma
A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma
The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.
- Trial name
- MONA (NCT00686335)
- Testing
- Lodotra, Cortancyl
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Amgen
Thyroid Associated Ophthalmopathies, Thyroid-Associated Ophthalmopathy
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison to placebo, in the treatment…
- Trial name
- NCT01868997
- Testing
- teprotumumab, normal saline
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 88 people
- Sponsor
- Amgen
Juvenile Idiopathic Arthritis (JIA)
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
- Trial name
- NCT01544114
- Testing
- VIMOVO 250/20, VIMOVO 375/20, VIMOVO 500/20
- Where
- 17 sites in United States
- Volunteers
- 46 people
- Sponsor
- Amgen
Hepatic Encephalopathy
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
- Trial name
- NCT00597909
- Testing
- sodium phenylacetate and sodium benzoate injection 10% / 10%
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Amgen
Rheumatoid Arthritis
A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA).
- Trial name
- MIDORA (NCT04163991)
- Testing
- VIB4920
- Where
- 25 sites in United States, Poland
- Volunteers
- 78 people
- Sponsor
- Amgen
Juvenile Idiopathic Arthritis
Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis
The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24…
- Trial name
- NCT01563185
- Testing
- 800 mg ibuprofen/26.6 mg famotidine
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Amgen
Peptic Ulcer
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
- Trial name
- NCT00450658
- Testing
- HZT-501, Ibuprofen
- Volunteers
- 627 people
- Sponsor
- Amgen
Psoriasis
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.
- Trial name
- NCT03701763
- Testing
- Apremilast (CC-10004)
- Where
- 99 sites in United States, Belgium and 8 more
- Volunteers
- 245 people
- Sponsor
- Amgen
Ulcer
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
- Trial name
- NCT00450216
- Testing
- Ibuprofen/famotidine, Ibuprofen
- Volunteers
- 906 people
- Sponsor
- Amgen
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