Clinical trials: Medication Safety
Tuberculosis, HIV Infections
Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis
This study evaluated the safety, tolerability, and pharmacokinetics of the anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in combination, among participants (with or without HIV co-infection) taking…
- Trial name
- NCT02583048
- Testing
- Bedaquiline, Delamanid, Dolutegravir
- Where
- 3 sites in Peru, South Africa
- Volunteers
- 84 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Mucopolysaccharidosis Type 7
An Open-Label Phase 1/2 Study to Assess the Safety, Efficacy and Dose of Study Drug UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis Type 7 (MPS 7)
UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of UX003 in MPS 7 patients via intravenous (IV) administration every other week (QOW) for 36 weeks with up to an additional 36 weeks from the…
- Trial name
- NCT01856218
- Testing
- UX003
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Essential Hypertension
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone
The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential…
- Trial name
- NCT01456169
- Testing
- Azilsartan medoxomil - chlorthalidone
- Where
- 108 sites in Bulgaria, Estonia and 12 more
- Volunteers
- 507 people
- Sponsor
- Takeda
HIV Infections
PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.
The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.
- Trial name
- NCT00736502
- Where
- 17 sites in Austria, Poland
- Volunteers
- 280 people
- Sponsor
- Boehringer Ingelheim
Generalized Anxiety Disorder
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6…
- Trial name
- GAD (NCT00368745)
- Testing
- Pregabalin
- Where
- 21 sites in Costa Rica, Czechia and 5 more
- Volunteers
- 108 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Schizophrenia
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04072354
- Testing
- SEP-363856 50mg, SEP-363856 75mg
- Where
- 53 sites in United States, Bulgaria and 4 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding…
- Trial name
- NCT03557931
- Testing
- ASP4345, risperidone, quetiapine
- Where
- 27 sites in United States
- Volunteers
- 233 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
Ovarian Cancer, Fallopian Tube Cancer
Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer
The purpose of this study is to evaluate the safety and efficacy of niraparib in participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT03759600
- Testing
- Niraparib
- Where
- 33 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Takeda
Epilepsy
Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures
The immediate release (IR) formulation of retigabine has been shown to be superior to placebo as adjunctive therapy in 3 adequate and well-controlled studies in subjects with drug-resistant partial-onset seizures (POS) who had…
- Trial name
- NCT01648101
- Testing
- Retigabine 900mg/day, Retigabine 600mg/day
- Where
- 41 sites in Hong Kong, Malaysia and 5 more
- Volunteers
- 76 people
- 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.
Parkinson Disease, Healthy Participants
A Study of TAK-071 in People With Parkinson Disease
It is hoped that TAK-071 will help people with Parkinson's disease to walk with better balance. The main aim of the study is to check if there is a difference in how participants walk after treatment with TAK-071.
- Trial name
- NCT04334317
- Testing
- TAK-071
- Where
- 21 sites in United States
- Volunteers
- 64 people
- Sponsor
- Takeda
Non Small Cell Lung Cancer, Lung Cancer Stage 1
Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients
The purpose of this study is to assess pain management after elective thoracoscopic lobectomy. The study will compare two local anesthetics that are given intra-operatively during lobectomy to see which one helps in better pain…
- Trial name
- BEMP (NCT03682224)
- Testing
- Liposomal Bupivacaine, Bupivacaine-Epinephrine
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Southern Illinois University
Infection, Human Immunodeficiency Virus, HIV Infections
Study to Evaluate a HIV Drug for the Treatment of HIV Infection
The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients
- Trial name
- NCT01803074
- Testing
- BMS-955176, Atazanavir, Ritonavir
- Where
- Germany
- Volunteers
- 107 people
- Sponsor
- ViiV Healthcare
Complicated Intra-abdominal Infection
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
- Trial name
- RECLAIM3 (NCT01726023)
- Testing
- Ceftazidime-avibactam, metronidazole, Meropenem
- Where
- 30 sites in China, South Korea and 1 more
- Volunteers
- 486 people
- Sponsor
- Pfizer
Diabetes, Diabetes Mellitus, Type 2
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).
- Trial name
- SUSTAIN™1 (NCT02054897)
- Testing
- semaglutide
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 388 people
- Sponsor
- Novo Nordisk A/S
Hypertension
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension
Single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive…
- Trial name
- NCT01499810
- Testing
- Bilateral radiofrequency sympathetic renal denervation
- Where
- Russia
- Volunteers
- 53 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin Reexamination Study (0653A-174)
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting…
- Trial name
- NCT01070966
- Volunteers
- 2,089 people
- Sponsor
- Organon and Co
Erosive Esophagitis
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI)…
- Trial name
- NCT02388737
- Testing
- Vonoprazan, Lansoprazole
- Where
- 72 sites in China, Malaysia and 2 more
- Volunteers
- 703 people
- Sponsor
- Takeda
Diabetes Mellitus, Type 2
Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
Primary Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.
- Trial name
- BRIGHT (NCT02738151)
- Testing
- Insulin glargine, 300U/mL, Insulin degludec, 100 U/mL, Non-insulin anti-diabetic treatment
- Where
- 158 sites in United States, Bulgaria and 14 more
- Volunteers
- 929 people
- Sponsor
- Sanofi
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