Clinical trials: Adverse Drug Event
Type 2 Diabetes Mellitus
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
- Trial name
- SURPASS-CVOT (NCT04255433)
- Testing
- Tirzepatide, Dulaglutide
- Where
- 635 sites in United States, Argentina and 29 more
- Volunteers
- 13,299 people
- Sponsor
- Eli Lilly and Company
Anemia, Kidney Diseases
DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect \& describe less common adverse drug reactions, and to…
- Conditions
- Anemia, Kidney Diseases, Renal Failure, Chronic, Kidney Failure, Chronic
- Trial name
- DELFT (NCT00664066)
- Testing
- DYNEPO (epoetin delta)
- Where
- 2 sites in Germany
- Volunteers
- 3 people
- Sponsor
- Shire
Rheumatoid Arthritis (RA)
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function.
- Trial name
- NCT04888585
- Testing
- ABBV-154
- Where
- 220 sites in United States, Australia and 19 more
- Volunteers
- 473 people
- Sponsor
- AbbVie
Submental Fat
Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events
This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:
- Trial name
- NCT05476679
- Testing
- RZL-012, RZL-012+Lidacaine injection prior treatment, RZL-012+Medrol
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Raziel Therapeutics Ltd.
Acute Pain, Dysmenorrhea
Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury.
- Trial name
- NCT02910167
- Testing
- Hyoscine n-butylbromide, Paracetamol
- Where
- Peru
- Volunteers
- 360 people
- Sponsor
- Boehringer Ingelheim
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
Drug Safety
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients…
- Trial name
- NCT01475097
- Testing
- Iodixanol, Iopamidol
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- GE Healthcare
Schizophrenia, Bipolar Disorder
A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events…
- Conditions
- Schizophrenia, Bipolar Disorder, Autistic Disorder, Conduct and Other Disruptive Behavior Disorders
- Trial name
- NCT01050582
- Testing
- Risperidone, Other atypical antipsychotic drugs
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 244 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Adverse Drug Events, Adverse Drug Reactions
Pharmacogenetic Testing Among Home Health Patients
Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing.
- Conditions
- Adverse Drug Events, Adverse Drug Reactions, Drug Interaction Potentiation, Drug Metabolism, Poor, CYP2D6-RELATED
- Trial name
- NCT02378220
- Testing
- Pharmacogenetic testing
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Genelex Corporation
Coronary Artery Disease, Clopidogrel Resistance
The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug…
- Conditions
- Coronary Artery Disease, Clopidogrel Resistance, Coronary Thrombosis, Adverse Cardiac Events
- Trial name
- NCT06665919
- Testing
- CYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel, The Conventional Clopidogrel Treatment
- Where
- 4 sites in Georgia
- Volunteers
- 283 people
- Sponsor
- Vistamedi Ltd.
Renal Cell Carcinoma
To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma
To assess how dose reductions or treatment interruptions related to axitinib can be implemented to manage and resolve adverse events occurring among patients with advanced renal cell carcinoma treated with first-line axitinib in…
- Trial name
- NCT04682587
- Testing
- Axitinib, Avelumab, Pembrolizumab
- Where
- United States
- Volunteers
- 481 people
- Sponsor
- Pfizer
Obesity, Cardiovascular Diseases
Naltrexone/Bupropion Cardiovascular Outcomes Study
The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo and rule out excess risk of major adverse…
- Trial name
- NCT02638129
- Testing
- Naltrexone HCl/Bupropion HCl ER
- Where
- 139 sites in United States
- Volunteers
- 67 people
- Sponsor
- Orexigen Therapeutics, Inc
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Multiple Myeloma
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies.
- Trial name
- NCT03525678
- Testing
- Belantamab mafodotin frozen liquid, Belantamab mafodotin lyophilized powder
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 221 people
- Sponsor
- GlaxoSmithKline