Clinical trials: Medication Safety
Influenza
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year.
- Trial name
- NCT02381418
- Testing
- Trivalent influenza subunit vaccine Influvac
- Where
- Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Abbott
Pharmacokinetics, Cytochrome P-450 CYP2D6
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy adult subjects.
- Conditions
- Pharmacokinetics, Cytochrome P-450 CYP2D6, CYP3A4 Protein, Human
- Trial name
- NCT01188668
- Testing
- Aripiprazole, Aripiprazole + desvenlafaxine succinate sustained release
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Pfizer
Stomach Ulcer, Duodenal Ulcer
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term…
- Trial name
- NCT00762359
- Testing
- Lansoprazole, Gefarnate
- Where
- 65 sites in Japan
- Volunteers
- 461 people
- Sponsor
- Takeda
Ulcerative Colitis, Crohn Disease
A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab.
- Trial name
- NCT04804540
- Testing
- Vedolizumab IV
- Where
- 17 sites in India
- Volunteers
- 150 people
- Sponsor
- Takeda
Eosinophilic Esophagitis
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538.
- Trial name
- NCT04991935
- Testing
- CC-93538
- Where
- 167 sites in United States, Argentina and 13 more
- Volunteers
- 367 people
- Sponsor
- Celgene
Chronic Kidney Disease
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa…
- Trial name
- EPO-PASS (NCT00632125)
- Testing
- HX575 recombinant human erythropoietin alfa
- Where
- 114 sites in Austria, Bulgaria and 8 more
- Volunteers
- 1,695 people
- Sponsor
- Sandoz
Tardive Dyskinesia
Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
- Trial name
- NCT03176771
- Testing
- MT-5199
- Where
- 82 sites in Japan
- Volunteers
- 256 people
- Sponsor
- Tanabe Pharma Corporation
Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis
BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
This is a prospective, open label, two-centre, randomized, controlled, two-stage, phase Ib/IIa study to evaluate the safety, tolerability, PK, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once…
- Trial name
- NCT04044001
- Testing
- BTZ-043, Rifafour e-275®, Probe Drug Cocktail
- Where
- 2 sites in South Africa
- Volunteers
- 78 people
- Sponsor
- Michael Hoelscher
Osteoarthritis
A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee…
- Trial name
- ITIC (NCT00565812)
- Testing
- SD-6010
- Where
- 183 sites in United States, Argentina and 12 more
- Volunteers
- 1,457 people
- Sponsor
- Pfizer
Asthma
Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma
This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.
- Trial name
- NCT04987944
- Testing
- Zavegepant
- Where
- 10 sites in Canada
- Volunteers
- 45 people
- Sponsor
- Pfizer
Epilepsy, Partial Seizures
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with…
- Trial name
- NCT01063764
- Testing
- Levetiracetam
- Where
- 29 sites in Japan
- Volunteers
- 73 people
- Sponsor
- UCB Japan Co. Ltd.
Heart Failure With Reduced Ejection Fraction, HIV Infections
Heart Failure Polypill at a Safety Net Hospital
A novel four-drug regimen for heart failure with reduced ejection fraction (HFrEF) extends patients' life expectancy by an average of 6 years compared to traditional therapies, in addition to improving quality of life.
- Trial name
- NCT06029712
- Testing
- Heart failure polypill, Control Rx
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of California, San Francisco
Beta-Thalassemia
A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Participants With Transfusion-Dependent β-Thalassemia
This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 18 participants less than or equal to (<=) 50 years of age with transfusion-dependent β-thalassemia (TDT), who have a β0/β0, β0/IVS-I-110, or…
- Trial name
- NCT03207009
- Testing
- LentiGlobin BB305 Drug Product
- Where
- 9 sites in United States, France and 4 more
- Volunteers
- 19 people
- Sponsor
- Genetix Biotherapeutics Inc.
Glaucoma, Neovascular
Study to Learn How the Drug Aflibercept Works in in Japanese Patients With Increased Eye Pressure That is Caused by New Blood Vessels Growing in the Eye (Neovascular Glaucoma or NVG). Safety of the Drug and Patients' Tolerability of the Drug Injection is Also Studied
The researchers in this trial want to learn how the drug aflibercept works in in Japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or NVG).
- Trial name
- VENERA (NCT03639675)
- Testing
- Aflibercept (EYLEA, BAY86-5321), Topical IOP-lowering drugs
- Where
- 7 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Bayer
Infection, Human Immunodeficiency Virus, HIV Infections
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir…
- Trial name
- NCT02831764
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 722 people
- Sponsor
- ViiV Healthcare
Sanfilippo Syndrome, Mucopolysaccharidosis (MPS)
An Extension Study to Determine Safety and Efficacy for Pediatric Patients With MPS Type IIIA Disease Who Participated in Study HGT-SAN-093.
This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy…
- Trial name
- NCT02350816
- Testing
- HGT-1410
- Where
- 8 sites in United States, France and 5 more
- Volunteers
- 17 people
- Sponsor
- Shire
Healthy
A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerability of Safinamide in Healthy Adult Chinese Volunteers
This is a Phase I, single center, single and multiple-dose, open-label, randomised, parallel-group, pharmacokinetics, safety and tolerability study.
- Trial name
- NCT03887221
- Testing
- Safinamide 50 mg, Safinamide 100mg
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Zambon SpA
Depressive Disorder, Major
Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.
- Trial name
- NCT01153009
- Testing
- Vortioxetine, Duloxetine
- Where
- 56 sites in United States
- Volunteers
- 614 people
- Sponsor
- Takeda
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
- Trial name
- CAP (NCT00509106)
- Testing
- Ceftaroline fosamil for Injection, Ceftriaxone
- Where
- 134 sites in United States, Argentina and 13 more
- Volunteers
- 622 people
- Sponsor
- Forest Laboratories
Diabetes Mellitus, Type 2
A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.
- Trial name
- NCT05144984
- Testing
- NNC0480-0389, Semaglutide
- Where
- 129 sites in United States, Bulgaria and 7 more
- Volunteers
- 500 people
- Sponsor
- Novo Nordisk A/S
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