Clinical trials: Medication Safety
Healthy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects
This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, including food-effect.
- Trial name
- NCT04908800
- Testing
- KRP-A218, itraconazole
- Where
- United Kingdom
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Kyorin Pharmaceutical Co.,Ltd
Celiac Disease
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in…
- Trial name
- NCT05353985
- Testing
- TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
- Where
- 102 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Takeda
HIV-1-infection
Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine
The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial.
- Trial name
- NCT04538040
- Testing
- Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Quest Clinical Research
Essential Hypertension
A Phase III Long-term Study of TAK-536TCH in Participants With Essential Hypertension
The purpose of this study is to evaluate the safety of long-term administration of TAK-536, amlodipine (AML), and hydrochlorothiazide (HCTZ) in participants with essential hypertension.
- Trial name
- NCT02277691
- Testing
- TAK-536TCH tablet, TAK-536CCB tablet, HCTZ 12.5 mg tablet
- Where
- 38 sites in Japan
- Volunteers
- 341 people
- Sponsor
- Takeda
Presbyopia, Refractive Errors
Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (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
- NCT05431543
- Testing
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Vehicle proprietary ophthalmic solution
- Where
- 5 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- LENZ Therapeutics, Inc
Type 2 Diabetes Mellitus
Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2 diabetic patients with inadequate glycemic…
- Trial name
- NCT02068443
- Testing
- Alogliptin, Metformin hydrochloride
- Where
- 27 sites in Japan
- Volunteers
- 374 people
- Sponsor
- Takeda
Prostatic Cancer
Quinacrine Treatment in Patients With Androgen-Independent Prostate Cancer
The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer.
- Trial name
- NCT00417274
- Testing
- Quinacrine
- Volunteers
- 31 people
- Sponsor
- Cleveland BioLabs
Clear-cell Metastatic Renal Cell Carcinoma
MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma
The purpose of this study is to evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell…
- Trial name
- NCT02724020
- Testing
- Everolimus, MLN0128, MLN1117
- Where
- 36 sites in United States, Canada and 6 more
- Volunteers
- 96 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Type 2 Diabetes
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone.
- Trial name
- NCT00528879
- Testing
- Dapagliflozin, Metformin
- Where
- 75 sites in United States, Argentina and 3 more
- Volunteers
- 915 people
- Sponsor
- AstraZeneca
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
Psychotic Disorders
This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year
This is a study in people between 16 and 30 years of age who have a specific type of mental illness called attenuated psychosis syndrome (APS).
- Trial name
- NCT03230097
- Testing
- BI 409306
- Where
- 33 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes.
- Trial name
- COMBINE 1 (NCT05352815)
- Testing
- IcoSema, Insulin icodec
- Where
- 281 sites in United States, Australia and 20 more
- Volunteers
- 1,291 people
- Sponsor
- Novo Nordisk A/S
Beta-Thalassemia Major, Sickle Cell Disease
A Study Evaluating the Safety and Efficacy of LentiGlobin BB305 Drug Product in β-Thalassemia Major (Also Referred to as Transfusion-dependent β-Thalassemia [TDT]) and Sickle Cell Disease
This is a Phase 1/2, open label, safety, and efficacy study of the administration of LentiGlobin BB305 Drug Product to participants with either transfusion dependent beta-thalassemia (TDT) or sickle cell disease (SCD).
- Trial name
- NCT02151526
- Testing
- LentiGlobin BB305 Drug Product
- Where
- France
- Volunteers
- 7 people
- Sponsor
- Genetix Biotherapeutics Inc.
Paroxysmal Atrial Fibrillation
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
- Trial name
- FROZEN-AF (NCT04133168)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 44 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
Cardiovascular Disease
Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)
The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).
- Trial name
- CARES (NCT01101035)
- Testing
- Febuxostat, Allopurinol
- Where
- 203 sites in United States, Mexico
- Volunteers
- 6,198 people
- Sponsor
- Takeda
Medication Adherence
Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.
The purpose of this project is to test whether an online pain medication intervention is a feasible and effective way to increase opioid pain medication safety.
- Trial name
- NCT01770314
- Testing
- Experimental
- Where
- United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Inflexxion, Inc.
Head and Neck Neoplasms, Lung Neoplasms
Imaging Study for FdCyd and THU Cancer Treatment
Background: The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body.
- Conditions
- Head and Neck Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Breast Neoplasms
- Trial name
- NCT01479348
- Testing
- [F-18]-5-FLUORO-2'-DEOXYCYTIDINE, Tetrahydrouridine intravenous (IV), Tetrahydrouridine (oral)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
Type 2 Diabetes Mellitus
Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who…
- Trial name
- NCT01263509
- Testing
- Alogliptin and voglibose
- Volunteers
- 179 people
- Sponsor
- Takeda
Non-small Cell Lung Cancer
A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus…
- Trial name
- STELLA (NCT03296163)
- Testing
- MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin®, Carboplatin
- Where
- 118 sites in Brazil, Bulgaria and 16 more
- Volunteers
- 627 people
- Sponsor
- mAbxience Research S.L.
Pancreatic Cancer, Hepatocellular Cancer
A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors
This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors.
- Conditions
- Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma, Breast Cancer
- Trial name
- NCT05070247
- Testing
- TAK-500, Pembrolizumab, Tocilizumab
- Where
- 12 sites in United States
- Volunteers
- 61 people
- Sponsor
- Takeda
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