Clinical trials: Medication Safety
Healthy Volunteers
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to…
- Trial name
- TIDES (NCT02747927)
- Testing
- Tetravalent Dengue Vaccine (TDV)
- Where
- 28 sites in Brazil, Colombia and 6 more
- Volunteers
- 20,099 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU Avastin® in healthy male subjects.
- Trial name
- NCT04238663
- Testing
- MB02 (Bevacizumab Biosimilar), EU approved Avastin®, US licenced Avastin®
- Where
- Germany
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Rheumatoid Arthritis
To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)
Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
- Trial name
- NCT01768572
- Testing
- sarilumab SAR153191 (REGN88), tocilizumab, hydroxychloroquine
- Where
- 78 sites in United States, Argentina and 17 more
- Volunteers
- 202 people
- Sponsor
- Sanofi
Chronic Hepatitis C Infection
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as ombitasvir] and ABT-333 [also known as…
- Trial name
- MALACHITE II (NCT01854528)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin, Pegylated Interferon a-2a (PegINF)
- Volunteers
- 148 people
- Sponsor
- AbbVie
Schizophrenia
Long-term Study of Cariprazine in Patients With Schizophrenia
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
- Trial name
- NCT01104792
- Testing
- Cariprazine
- Where
- 86 sites in United States, Colombia and 4 more
- Volunteers
- 752 people
- Sponsor
- Forest Laboratories
Ischemic Heart Disease
Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
The purpose of this study is to evaluate the safety of VM202 (Engensis) direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery…
- Trial name
- Engensis (NCT01422772)
- Testing
- VM202-0.5 mg, VM202-1.0 mg, VM202-2.0 mg
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Helixmith Co., Ltd.
Hemodialysis Access Failure
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
- Trial name
- NCT03734679
- Testing
- SurVeil Drug Coated Balloon
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 12 people
- Sponsor
- SurModics, Inc.
Obesity, Overweight
A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects
The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.
- Trial name
- NCT00532779
- Testing
- Naltrexone SR 16 mg/Bupropion SR 360 mg /day, Naltrexone SR 32 mg/Bupropion SR 360 mg /day, Ancillary therapy
- Where
- 34 sites in United States
- Volunteers
- 1,742 people
- Sponsor
- Orexigen Therapeutics, Inc
Epilepsy
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on…
- Trial name
- NCT02201251
- Testing
- Topiramate, Levetiracetam
- Where
- 41 sites in United States, Argentina and 12 more
- Volunteers
- 63 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model
An endotoxin challenge will be administered to healthy subjects to induce production of inflammatory markers. An investigational drug or placebo will be administered prior to the endotoxin challenge to assess the effect of the…
- Trial name
- POM (NCT01965600)
- Testing
- PF-06282999, LPS
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03949621
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Presbyopia, Refractive Errors
Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
- Conditions
- Presbyopia, Refractive Errors, Eye Diseases
- Trial name
- NCT05294328
- Testing
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Vehicle Proprietary Ophthalmic Solution
- Where
- 5 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- LENZ Therapeutics, Inc
Urologic Diseases, Urinary Bladder, Overactive
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of…
- Conditions
- Urologic Diseases, Urinary Bladder, Overactive, Urinary Bladder Diseases
- Trial name
- BEYOND (NCT01638000)
- Testing
- Mirabegron, Solifenacin succinate
- Where
- 217 sites in Armenia, Austria and 31 more
- Volunteers
- 1,887 people
- Sponsor
- Astellas Pharma Europe Ltd.
Narcolepsy Type 1
A Study of TAK-861 for the Treatment of Narcolepsy Type 1
The main aim of this study is to learn how effective TAK-861 (oveporexton) is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment.
- Trial name
- NCT06470828
- Testing
- Oveporexton
- Where
- 53 sites in United States, Canada and 9 more
- Volunteers
- 168 people
- Sponsor
- Takeda
Tardive Dyskinesia
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or…
- Trial name
- NCT01393600
- Testing
- NBI-98854
- Where
- 11 sites in United States
- Volunteers
- 37 people
- Sponsor
- Neurocrine Biosciences
Diabetes Mellitus
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.
- Trial name
- NCT00306384
- Testing
- Alogliptin
- Where
- 114 sites in United States, Argentina and 10 more
- Volunteers
- 3,323 people
- Sponsor
- Takeda
Gonorrhoea
Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male and female subjects, between the ages of 18 and 55, who are in good health and meet all eligibility criteria.
- Trial name
- NCT02257918
- Testing
- AZD0914, Ceftriaxone
- Where
- 5 sites in United States
- Volunteers
- 180 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tardive Dyskinesia (TD)
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
- Trial name
- NCT03891862
- Testing
- Valbenazine
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 135 people
- Sponsor
- Neurocrine Biosciences
Liver Transplantation
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients.
- Trial name
- NCT00545402
- Testing
- Mycophenolate mofetil, adjusted dose, Tacrolimus, Corticosteroids, IV
- Where
- 16 sites in France
- Volunteers
- 180 people
- Sponsor
- Hoffmann-La Roche
Advanced Nonhematologic Malignancies
A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies
The purpose of this study was to evaluate the safety and to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and dosing schedules of oral TAK-228+TAK-117.
- Trial name
- NCT01899053
- Testing
- TAK-228, TAK-117
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 101 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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