Clinical trials: Adverse Drug Events
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer
Adverse Reaction
Knowledge and Practices of ADR Reporting in LMICs
The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries.
- Trial name
- NCT04301219
- Where
- Pakistan
- Volunteers
- 1,500 people
- Sponsor
- Getz Pharma
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.
Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months
An Observational Study to Evaluate the Incidence of MACCE According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding
This study is to evaluate the incidence rate of Major Adverse CardioCerebrovascular Events(MACCE) in Patients with Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the secondary prevention and Esomezol Cap for…
- Trial name
- NCT05487560
- Testing
- Esomezol Cap
- Where
- South Korea
- Volunteers
- 4,133 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Leishmaniasis; American, Cutaneous, Drug Side Effect
Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients
It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.
- Trial name
- NCT03084952
- Testing
- 18-Methoxycoronaridine, Glucantime
- Volunteers
- 52 people
- Sponsor
- Infan Industria Quimica Farmaceutica Nacional
Target Drug-related Adverse Events
Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens
The purpose of this study is to determine whether the addition of selective pharmacogenomic (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced by a reduction in Target Drug-related…
- Trial name
- SPHERE (NCT02625155)
- Testing
- Urine diagnostic testing as SOC, drug regimen changes per SOC, Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results
- Where
- United States
- Volunteers
- 14,000 people, healthy volunteers welcome
- Sponsor
- InSource Diagnostics
Ovarian Cancer
A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Other Anticancer Drugs in Adult Participants With Ovarian Cancer
Ovarian cancer (OC) is a lethal disease. The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABBV901, alone or in combination with other anticancer drugs, in participants with ovarian cancer.
- Trial name
- NCT07278336
- Testing
- ABBV-901, Bevacizumab, Carboplatin
- Where
- 27 sites in United States, Australia and 6 more
- Volunteers
- 285 people
- Sponsor
- AbbVie
Adverse Drug Reactions
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review.
- Trial name
- NCT01354730
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Adimmune Corporation
Adverse Drug Events, Adverse Drug Reactions
YouScript IMPACT Registry
This multicenter observational study aims to investigate the benefits of providing pharmacogenetic testing with the YouScript Personalized Prescribing System which includes a clinical decision support tool and individualized…
- Conditions
- Adverse Drug Events, Adverse Drug Reactions, Drug Interaction Potentiation, Drug Metabolism, Poor, CYP2D6-RELATED
- Trial name
- IMPACT (NCT02191358)
- Where
- 7 sites in United States
- Volunteers
- 800 people
- Sponsor
- Genelex Corporation
Drug Side Effects
Pharmacogenomics Registry to Assess Clinical Utility
The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects…
- Trial name
- PREACT (NCT02374840)
- Volunteers
- 340,778 people
- Sponsor
- Companion Dx Reference Lab, LLC
Tumor Infiltrating Lymphocytes, Safety
A Phase I Study of GC101 TIL in Advanced Solid Tumors
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor, Immunotherapy
- Trial name
- MIZAR-001 (NCT05417750)
- Testing
- TIL therapy
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Shanghai Juncell Therapeutics
Juvenile Psoriatic Arthritis
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time.
- Trial name
- NCT06100744
- Testing
- Adalimumab, Risankizumab
- Where
- 34 sites in United States, Australia and 7 more
- Volunteers
- 40 people
- Sponsor
- AbbVie
Healthy Volunteer Study
Safety Study of CZ10 in Healthy Volunteers
A randomized, double-blind, placebo-controlled, parallel group, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and initial effectiveness of a novel intravenous CT contrast…
- Trial name
- NCT06708767
- Testing
- Contrast Media
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Nextrast, 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
Parkinson Disease
A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)
The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina…
- Trial name
- NCT04724109
- Testing
- Equfina
- Where
- 2 sites in Japan
- Volunteers
- 1,088 people
- Sponsor
- Eisai Co., Ltd.
Non-Small Cell Lung Cancer (NSCLC)
A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788
The purpose of the study is to characterize the incidence and severity of TAK-788-associated diarrhea in previously treated participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors harbor…
- Trial name
- NCT04576208
- Testing
- TAK-788, Antidiarrheal prophylaxis
- Sponsor
- Takeda
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04339634
- Testing
- Simulation of Repurposed Drugs for COVID-19
- Where
- United States
- Volunteers
- 12,873 people
- Sponsor
- Tabula Rasa HealthCare
Hypertension
Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension
In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism.
- Trial name
- NCT02177331
- Testing
- Lacidipine
- Volunteers
- 53 people
- Sponsor
- Boehringer Ingelheim
Advanced Solid Tumors
Phase I Study of KN044 in Locally Advanced/Metastatic Solid Tumors
This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN044 in participants with all advanced solid tumors who are not able to have current standard…
- Trial name
- NCT04126590
- Testing
- KN044
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Changchun Intellicrown Pharmaceutical Co. LTD
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