Clinical trials: Medication Safety
HIV Infections
Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients.
- Trial name
- NCT01524900
- Where
- 53 sites in Austria, Poland and 1 more
- Volunteers
- 398 people
- Sponsor
- Boehringer Ingelheim
Helicobacter Pylori
A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection
The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.
- Trial name
- NCT04198363
- Testing
- Vonoprazan, Amoxicillin, Clarithromycin
- Where
- 29 sites in China
- Volunteers
- 510 people
- Sponsor
- Takeda
Type 2 Diabetes Mellitus
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
This was a parallel-group treatment, Phase 3, randomized, 2-arm study that assessed the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s).
- Trial name
- NCT05413369
- Testing
- Insulin glargine/Lixisenatide, IDegAsp, Metformin
- Where
- 60 sites in China
- Volunteers
- 582 people
- Sponsor
- Sanofi
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
Healthy Volunteers, Male
A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers
A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy…
- Conditions
- Healthy Volunteers, Male, Japanese
- Trial name
- NCT04238650
- Testing
- MB02 (Bevacizumab Biosimilar), EU approved Avastin®
- Where
- Japan
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Osteoarthritis, Knee, Osteoarthritis, Hip
Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.
- Trial name
- FACT OA2 (NCT03304379)
- Testing
- Fasinumab, Diclofenac, Celecoxib
- Where
- 71 sites in United States
- Volunteers
- 1,650 people
- Sponsor
- Regeneron Pharmaceuticals
TTR-mediated Amyloidosis, Amyloidosis, Hereditary
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis.
- Conditions
- TTR-mediated Amyloidosis, Amyloidosis, Hereditary, Amyloid Neuropathies, Familial, Familial Amyloid Polyneuropathies
- Trial name
- NCT01960348
- Testing
- patisiran (ALN-TTR02), Sterile Normal Saline (0.9% NaCl)
- Where
- 52 sites in United States, Argentina and 19 more
- Volunteers
- 225 people
- Sponsor
- Alnylam Pharmaceuticals
Depressive Disorder, Major
Safety and Efficacy Study 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
- NCT01179516
- Testing
- Vortioxetine
- Where
- 61 sites in United States
- Volunteers
- 469 people
- Sponsor
- Takeda
HIV
Emtricitabine/Tenofovir Alafenamide as Salvage ART
Background: HIV attacks the immune system. Antiretroviral therapy (ART) is a combination of drugs used for treating HIV infection. For some people, ART drugs stop working against their HIV.
- Trial name
- NCT02556333
- Testing
- FTC/TAF
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HSV-2
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
- Trial name
- NCT01047540
- Testing
- AIC316
- Where
- 6 sites in United States
- Volunteers
- 156 people
- Sponsor
- AiCuris Anti-infective Cures AG
Attention Deficit Hyperactivity Disorder
Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study.
- Trial name
- ADHD SWITCH (NCT00760747)
- Testing
- Atomoxetine
- Where
- 6 sites in Australia, Mexico and 1 more
- Volunteers
- 112 people
- Sponsor
- Eli Lilly and Company
Infertility
Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)
The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).
- Trial name
- NCT03858049
- Testing
- Crinone, Duphaston
- Where
- China
- Volunteers
- 172 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy…
- Trial name
- NCT01596335
- Testing
- TA-650, Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
- Where
- 8 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Tanabe Pharma Corporation
Hypertriglyceridemia
Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia…
- Trial name
- NCT01350999
- Testing
- omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA)
- Volunteers
- 503 people
- Sponsor
- Takeda
Tuberculosis
A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB
This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity study in adults who have recently been successfully treated for drug-susceptible pulmonary Tuberculosis (TB).
- Trial name
- C-037-456 (NCT02375698)
- Testing
- H56:IC31
- Where
- 3 sites in South Africa
- Volunteers
- 22 people
- Sponsor
- Aeras
Norovirus
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children
The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for further development in children.
- Trial name
- NCT02153112
- Testing
- GI.1/GII.4 (15/15), GI.1/GII.4 (15/50), GI.1/GII.4 (50/50)
- Where
- 12 sites in Colombia, Finland and 1 more
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived…
- Trial name
- NCT03522506
- Testing
- TAK-925, Modafinil
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Infections, Bacterial
Drug-drug Interaction Study of Gepotidacin
This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort.
- Trial name
- NCT04493931
- Testing
- Gepotidacin, Cimetidine, Rifampicin
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Epilepsy With Simple or Complex Partial Onset Seizures
Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.
- Trial name
- NCT00866775
- Testing
- Eslicarbazepine acetate
- Where
- 106 sites in United States, Canada
- Volunteers
- 193 people
- Sponsor
- Sumitomo Pharma America, Inc.
Tuberculosis, Pulmonary, Tuberculosis, MDR
Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
The purpose of this study is to assess the efficacy and safety of 2 repurposed drugs (acetylsalicylic acid and ibuprofen), for use as adjunct therapy added to, and compared with, the standard of care (SoC) WHO-recommended TB…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, MDR, Tuberculosis Infection
- Trial name
- SMA-TB (NCT04575519)
- Testing
- Control group, ASA group, IBU group
- Where
- 3 sites in Georgia, South Africa
- Volunteers
- 426 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
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