Clinical trials: Adverse Drug Event
Opioid-induced Constipation
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced…
- Trial name
- NCT03720613
- Testing
- Naldemedine, Lubiprostone, Naloxegol
- Where
- United States
- Volunteers
- 34,532 people
- Sponsor
- BioDelivery Sciences International
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
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint…
- Trial name
- NCT07607964
- Testing
- ABBV-519
- Where
- 15 sites in United States, Japan
- Volunteers
- 30 people
- Sponsor
- AbbVie
Major Depressive Disorder (MDD)
A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder
Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as…
- Trial name
- NCT06618118
- Testing
- Fosigotifator
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- AbbVie
Genetics of Drug Metabolism
Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on…
- Trial name
- POETRY (NCT02095769)
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 280,000 people
- Sponsor
- General Genetics Corporation
Urinary Tract Infections
Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting
This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and…
- Trial name
- NCT05091931
- Where
- 2 sites in United States
- Volunteers
- 3,308 people
- Sponsor
- Pathnostics
Genetics of Drug Metabolism
Diagnosing Adverse Drug Reactions Registry
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen.
- Trial name
- DART (NCT01970709)
- Where
- 49 sites in United States
- Volunteers
- 250,000 people
- Sponsor
- Renaissance RX
Pharmacogenetic Analysis to Reduce Events.
Medication Optimisation for Reducing Events in a Private Practice Setting
Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that…
- Trial name
- MORE (NCT00653653)
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Awenydd GmbH
Genetics of Drug Metabolism
Utility of PharmacoGenomics for Reducing Adverse Drug Effects
UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency…
- Trial name
- UPGRADE (NCT02081872)
- Where
- 41 sites in United States
- Volunteers
- 279,000 people
- Sponsor
- Companion Dx Reference Lab, LLC
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
Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems.
- Conditions
- Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
- Trial name
- NCT02428660
- Testing
- Pharmacogenetic testing, Software-based drug & gene interaction risk analysis, MTM
- Where
- United States
- Volunteers
- 341 people
- Sponsor
- Genelex Corporation
Drug-Related Side Effects and Adverse Reactions
DOAC ADRs Retrospective Study
This retrospective study's objective is to evaluate if Cipherome's algorithm could have predicted the serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).
- Trial name
- NCT04247919
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Cipherome, Inc.
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.
Parkinson's Disease, Dyskinesia
Capturing Parkinson's Disease Medication Side Effects During Daily Activities
The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity…
- Trial name
- NCT01429207
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Great Lakes NeuroTechnologies Inc.
Healthy Volunteer
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
- Trial name
- NCT06673238
- Testing
- ABBV-722
- Where
- 2 sites in United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- AbbVie
Adverse Drug Event, Effect of Drug
Research on Human Insulin rDNA Safety and Efficacy in Patients With Type 2 Diabetes Mellitus
Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing…
- Conditions
- Adverse Drug Event, Effect of Drug, Type 2 Diabetes Treated With Insulin
- Trial name
- RISE (NCT05161741)
- Testing
- Insulin
- Where
- Pakistan
- Volunteers
- 238 people
- Sponsor
- Getz Pharma
Adverse Reaction to Drug
Post-market Safety Reassessment of Ulinastatin for Injection
1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc ) 2.
- Trial name
- NCT02520570
- Testing
- ulinastatin
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.
Advanced Solid Tumor, Tumor Associated Lymph Node T Cell
Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination…
- Conditions
- Advanced Solid Tumor, Tumor Associated Lymph Node T Cell, Immunotherapy
- Trial name
- TAL-T (NCT06302062)
- Testing
- Tumor Associated Lymph node T cell, cyclophosphamide, IL-2
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
Epilepsy
Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients
The purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment.
- Trial name
- NCT00394927
- Where
- 53 sites in Austria, Czechia and 5 more
- Volunteers
- 1,000 people
- Sponsor
- UCB Pharma
Safety Issues
Direct Acting Anti-Viral's In Chronic HCV Patients
The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated…
- Trial name
- NCT04664894
- Testing
- Sofosbuvir
- Where
- Pakistan
- Volunteers
- 511 people
- Sponsor
- Getz Pharma