Clinical trials: Patient Safety
Pancreatic Cancer
A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors
This Phase 1b/2 study will examine the effects of the study drugs, avelumab, binimetinib and talazoparib when given in a 2 (doublet) or 3 (triplet) drug combination, in patients with locally advanced or metastatic RAS-mutant…
- Trial name
- NCT03637491
- Testing
- Avelumab, Binimetinib, Talazoparib
- Where
- 18 sites in United States, Belgium and 1 more
- Volunteers
- 36 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: reduction of signs and symptoms at Week 24 and improvement of physical function at Week 12 in…
- Trial name
- NCT01709578
- Testing
- Sarilumab, hydroxychloroquine, methotrexate
- Where
- 196 sites in United States, Argentina and 28 more
- Volunteers
- 546 people
- Sponsor
- Sanofi
Chronic Myeloid Leukemia in Chronic Phase
Efficacy and Safety of LBH589 in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Chronic Phase
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
- Trial name
- NCT00451035
- Testing
- LBH589
- Where
- 10 sites in Belgium, Germany
- Volunteers
- 29 people
- Sponsor
- Novartis Pharmaceuticals
Attention Deficit Hyperactivity Disorder (ADHD)
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with…
- Trial name
- NCT02618408
- Testing
- SPN-810 (18 mg), SPN-810 (36 mg)
- Where
- 28 sites in United States
- Volunteers
- 333 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Hypertension
MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)
This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg [A5]) will be evaluated and compared to the…
- Trial name
- NCT01299376
- Testing
- L50/H12.5/A5, L50/H12.5
- Volunteers
- 286 people
- Sponsor
- Merck Sharp & Dohme LLC
Renal Transplantation
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g.
- Trial name
- NCT00154297
- Testing
- Everolimus (RAD001)
- Where
- Switzerland
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease (ESRD)
A Safety Study of Tocilizumab to Improve Transplant Rates in Highly Sensitized Patients Awaiting Kidney Transplantation
In this Phase I/II trial, 10 highly sensitized patients will be entered after informed consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg x 5 doses on days 15, 45, 75, 105, 119, 135, and…
- Trial name
- NCT01594424
- Testing
- Tocilizumab, Intravenous Immunoglobulin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cedars-Sinai Medical Center
FGFR Inhibition, Pharmacokinetics, Biomarkers, ER+ Breast Cancer
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)
- Trial name
- GLOW (NCT01202591)
- Testing
- AZD4547, Exemestane, Fulvestrant
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 127 people
- Sponsor
- AstraZeneca
Marginal Zone Lymphoma, Follicular Lymphoma
BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)
This was a multicenter, open-label, phase 2 study to evaluate efficacy, safety, and tolerability of BGB-3111 (zanubrutinib) 160 milligrams (mg) twice daily (BID) in combination with rituximab in Chinese participants with…
- Conditions
- Marginal Zone Lymphoma, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
- Trial name
- NCT03520920
- Testing
- Zanubrutinib, Rituximab
- Where
- 4 sites in China
- Volunteers
- 41 people
- Sponsor
- BeiGene
Corneal Epithelial Disorders
Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective in promoting corneal epithelial wound healing in conditions associated with corneal epithelial disorders.
- Trial name
- NCT02929823
- Testing
- High Dose SJP-0035 Ophthalmic Solution, Low Dose SJP-0035 Ophthalmic Solution, Vehicle of SJP-0035 Ophthalmic solution
- Where
- 19 sites in United States
- Volunteers
- 130 people
- Sponsor
- Senju Pharmaceutical Co., Ltd.
Mild Cognitive Impairment, Alzheimer Disease
Safety and Immunogenicity of Repeated Doses of ABvac40 in Patients With a-MCI or Vm-AD
Alzheimer's disease (AD) is the most common type of dementia, accounting for 50-75% of the estimated 47 million people with dementia worldwide.
- Trial name
- NCT03461276
- Testing
- ABvac40
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 134 people
- Sponsor
- Araclon Biotech S.L.
Hypertension
A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
- Trial name
- NCT00631917
- Testing
- Aliskiren, Ramipril
- Where
- 7 sites in United States, Argentina and 5 more
- Volunteers
- 774 people
- Sponsor
- Novartis
Myotonic Dystrophy 1, Excessive Daytime Sleepiness
Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.
- Trial name
- NCT04886518
- Testing
- Pitolisant Oral Tablet
- Where
- 13 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Harmony Biosciences Management, Inc.
Pain, Cancer
Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy.
- Trial name
- NCT00293020
- Testing
- BEMA Fentanyl
- Where
- United States
- Volunteers
- 244 people
- Sponsor
- BioDelivery Sciences International
Glaucoma, Ocular Hypertension
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between…
- Trial name
- NCT00383019
- Testing
- Xalatan, Xalacom
- Where
- 54 sites in Japan
- Volunteers
- 300 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Migraine Headache, With or Without Aura
Staccato Prochlorperazine in Migraine (in Clinic)
Development of Staccato Prochlorperazine for the treatment of migraine headache.
- Trial name
- NCT00610428
- Testing
- Staccato Prochlorperazine 5 mg, Staccato Prochlorperazine 10 mg
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Alexza Pharmaceuticals, Inc.
Tumors
A Study of IMC-A12 in Advanced Solid Tumors
In this study, participants will initially receive intravenous (IV) cixutumumab (IMC-A12) every 2 weeks or every 3 weeks for 6 weeks (one cycle).
- Trial name
- NCT01007032
- Testing
- Cixutumumab
- Where
- Japan
- Volunteers
- 21 people
- Sponsor
- Eli Lilly and Company
Atrial Fibrillation
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter…
- Trial name
- TACTIC AF (NCT01650298)
- Testing
- Drug (Direct thrombin or Factor Xa inhibitor)
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Nocturnal Hemoglobinuria
Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
A study to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic PNH.
- Trial name
- NCT01192399
- Testing
- Eculizumab
- Volunteers
- 29 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
COVID-19
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
- Trial name
- NCT04432298
- Testing
- Pamrevlumab
- Where
- 4 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Kyntra Bio
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