Clinical trials: sponsored by Amgen
Bone Metastases
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
- Trial name
- NCT00321464
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 2,049 people
- Sponsor
- Amgen
Multiple Myeloma, Waldenstrom Macroglobulinemia
Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.
- Trial name
- NCT01416428
- Testing
- oprozomib
- Where
- 19 sites in United States
- Volunteers
- 210 people
- Sponsor
- Amgen
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as…
- Trial name
- MENDEL (NCT01375777)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 3 more
- Volunteers
- 411 people
- Sponsor
- Amgen
Hyperlipidemia
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from…
- Trial name
- LAPLACE-2 (NCT01763866)
- Testing
- Evolocumab, Ezetimibe, Atorvastatin
- Where
- 244 sites in United States, Australia and 19 more
- Volunteers
- 2,067 people
- Sponsor
- Amgen
Idiopathic Thrombocytopenic Purpura
P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .
- Trial name
- NCT00603642
- Testing
- AMG 531
- Volunteers
- 34 people
- Sponsor
- Amgen
GCT, Giant Cell Tumor of Bone
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
- Trial name
- NCT00396279
- Testing
- Denosumab, Calcium/Vitamin D
- Volunteers
- 37 people
- Sponsor
- Amgen
Breast Cancer, Breast Neoplasms
Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic…
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Tumors, Cancer
- Trial name
- NCT00807859
- Testing
- AMG 386 30 mg/kg, Paclitaxel and Trastuzumab, AMG 386 30 mg/kg, Capecitabine and Lapatinib, AMG 386 10 mgkg, Paclitaxel and Trastuzumab
- Where
- 23 sites in United States, Belgium and 1 more
- Volunteers
- 65 people
- Sponsor
- Amgen
Idiopathic Thrombocytopenic Purpura, Thrombocytopenia
Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura
This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety…
- Conditions
- Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Thrombocytopenic Purpura
- Trial name
- NCT00415532
- Testing
- Medical Standard of Care for ITP, Romiplostim
- Volunteers
- 234 people
- Sponsor
- Amgen
Wild-type RAS Metastatic Colorectal Cancer
Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients
The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as…
- Trial name
- NCT01732783
- Testing
- Panitumumab + Chemotherapy
- Volunteers
- 213 people
- Sponsor
- Amgen
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density…
- Trial name
- MENDEL-2 (NCT01763827)
- Testing
- Evolocumab, Ezetimibe
- Where
- 83 sites in United States, Australia and 8 more
- Volunteers
- 615 people
- Sponsor
- Amgen
Heterozygous Familial Hypercholesterolemia
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
Cancer, Hematologic Malignancies
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology
- Trial name
- NCT01345019
- Testing
- Denosumab, Zoledronic acid, Denosumab (for the open-label treatment phase)
- Where
- 309 sites in United States, Australia and 27 more
- Volunteers
- 1,718 people
- Sponsor
- Amgen
Thrombocytopenia, Idiopathic Thrombocytopenic Purpura
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response.
- Trial name
- NCT00102336
- Testing
- AMG 531
- Volunteers
- 62 people
- Sponsor
- Amgen
Osteoporosis
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
- Trial name
- NCT00089791
- Testing
- Denosumab
- Volunteers
- 7,808 people
- Sponsor
- Amgen
Heart Failure, Anemia
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in…
- Conditions
- Heart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction
- Trial name
- NCT00358215
- Testing
- Darbepoetin alfa
- Where
- 754 sites in United States, Argentina and 34 more
- Volunteers
- 2,278 people
- Sponsor
- Amgen
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with…
- Trial name
- GAUSS (NCT01375764)
- Testing
- Evolocumab, Ezetimibe
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who…
- Trial name
- EVOLVE (NCT00345839)
- Testing
- Cinacalcet
- Volunteers
- 3,883 people
- Sponsor
- Amgen
Metastatic Colorectal Cancer
PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy
The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
- Trial name
- NCT00364013
- Testing
- Panitumumab, FOLFOX regimen
- Volunteers
- 1,183 people
- Sponsor
- Amgen
Healthy Subjects
A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
The primary objectives of the study are: to characterize the primary route(s) of elimination of [14C]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants…
- Trial name
- NCT05578859
- Testing
- AMG 510
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteopenia, Osteoporosis
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who…
- Trial name
- NCT00523341
- Testing
- Denosumab
- Volunteers
- 4,550 people
- Sponsor
- Amgen
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