Clinical trials: sponsored by Amgen
Hypercholesterolemia
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
- Trial name
- NCT02304484
- Testing
- Evolocumab
- Where
- 126 sites in United States, Argentina and 27 more
- Volunteers
- 770 people
- Sponsor
- Amgen
Osteoporosis, Postmenopausal
Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of…
- Trial name
- NCT01652690
- Testing
- Denosumab
- Where
- 29 sites in Czechia, Slovakia
- Volunteers
- 600 people
- Sponsor
- Amgen
Hypercholesterolemia
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery…
- Trial name
- GLAGOV (NCT01813422)
- Testing
- Evolocumab
- Where
- 226 sites in United States, Argentina and 30 more
- Volunteers
- 970 people
- Sponsor
- Amgen
Migraine
Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients
The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients.
- Trial name
- NCT01688739
- Testing
- Erenumab
- Where
- Belgium
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Amgen
Migraine
Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients.
- Trial name
- NCT01723514
- Testing
- Erenumab
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Vasomotor Symptoms; Hot Flashes
Study of Erenumab (AMG 334) in Women With Hot Flashes
The primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes associated with menopause.
- Trial name
- NCT01890109
- Testing
- Erenumab
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- Amgen
Diabetes, Hyperlipidemia, Mixed Dyslipidemia
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein…
- Trial name
- BERSON (NCT02662569)
- Testing
- Evolocumab, Atorvastatin
- Where
- 110 sites in United States, Argentina and 8 more
- Volunteers
- 986 people
- Sponsor
- Amgen
Anemia
A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy
The primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the…
- Trial name
- NCT03776032
- Testing
- Darbepoetin alfa
- Volunteers
- 320 people
- Sponsor
- Amgen
Headache, Migraine
Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females
A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.
- Trial name
- NCT02792517
- Testing
- Erenumab, Ethynil Estradiol/Norgestimate Oral Contraceptive
- Where
- 4 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Amgen
Primary Hyperparathyroidism
Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)
The primary objectives were to assess the safety and tolerability of twice daily (BID) doses of 65 mg cinacalcet administered orally to adults with primary HPT.
- Trial name
- NCT03776058
- Testing
- Cinacalcet
- Volunteers
- 10 people
- Sponsor
- Amgen
Primary Hyperparathyroidism
Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism
The primary objective was to assess the safety and tolerability of cinacalcet in adults with primary hyperparathyroidism (HPT) when administered as a single oral once daily doses for 6 consecutive weeks and twice daily for 15…
- Trial name
- NCT03774771
- Testing
- Cinacalcet
- Volunteers
- 48 people
- Sponsor
- Amgen
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
- Trial name
- NCT01849497
- Testing
- Evolocumab Pre-filled Syringe, Evolocumab AI/pen
- Where
- 26 sites in United States, Canada
- Volunteers
- 149 people
- Sponsor
- Amgen
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with…
- Trial name
- GAUSS-3 (NCT01984424)
- Testing
- Atorvastatin, Ezetimibe
- Where
- 58 sites in United States, Australia and 11 more
- Volunteers
- 511 people
- Sponsor
- Amgen
Homozygous Familial Hypercholesterolemia
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- TESLA (NCT01588496)
- Testing
- Evolocumab
- Where
- 21 sites in United States, Belgium and 10 more
- Volunteers
- 58 people
- Sponsor
- Amgen
Hypercholesterolemia and High Risk for Cardiovascular Events
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when…
- Trial name
- AMG145 (NCT01652703)
- Testing
- Evolocumab
- Where
- 42 sites in Japan
- Volunteers
- 310 people
- Sponsor
- Amgen
Heart Transplantation, Elevated Resting Heart Rate
An Interventional Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients
The hypothesis is that the treatment with ivabradine will increase pVO2 after 16 weeks of treatment compared to baseline in the heart transplant recipient population with elevated resting HR.
- Trial name
- NCT03619187
- Testing
- Ivabradine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Amgen
Squamous Cell Carcinoma of Head and Neck
A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study 20080008 was a PK sub-study to study 20050251[Japan 20050251A]. This PK protocol was amended 20-March-2009 and is now a Phase 2 stand alone study. There are no sites participating in the U.S.
- Trial name
- NCT00756444
- Testing
- Panitumumab, Cisplatin, 5FU
- Volunteers
- 67 people
- Sponsor
- Amgen
Myelodysplastic Syndrome (MDS)
Darbepoetin Alfa MDS Companion Protocol
The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for…
- Trial name
- NCT02175277
- Testing
- Darbepoetin Alfa
- Where
- 4 sites in Belgium
- Volunteers
- 9 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
- Trial name
- NCT02016716
- Testing
- Romosozumab 90 mg/mL, Romosozumab 70 mg/mL
- Where
- 12 sites in United States, Czechia and 1 more
- Volunteers
- 294 people
- Sponsor
- Amgen
Hyperlipidemia
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin
The purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.
- Trial name
- NCT01133522
- Testing
- Evolocumab
- Volunteers
- 60 people
- Sponsor
- Amgen
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