Clinical trials: High-risk Medications
- Condition High-risk Medications
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Asthma
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp…
- Trial name
- NCT01576718
- Testing
- Fp MDPI, Flovent Diskus, albuterol/salbutamol
- Where
- 300 sites in United States, Australia and 17 more
- Volunteers
- 889 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
ACUTE LYMPHOBLASTIC LEUKEMIA
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years)…
- Trial name
- NCT05748171
- Testing
- Inotuzumab ozogamicin, ALLR3
- Where
- 65 sites in Austria, Belgium and 13 more
- Volunteers
- 100 people
- Sponsor
- Pfizer
Glioblastoma
Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas
This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma.
- Trial name
- INTELLANCE-2 (NCT02343406)
- Testing
- Depatuxizumab mafodotin, Temozolomide, Lomustine
- Where
- 102 sites in United States, Australia and 19 more
- Volunteers
- 266 people
- Sponsor
- AbbVie
Hypertension
A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure
The main aim of this study is to check for side effects from treatment with azilsartan and how well azilsartan controls blood pressure in children from 6 to less than 16 years old with high blood pressure.
- Trial name
- NCT05107960
- Testing
- Azilsartan (TAK-536)
- Where
- Japan
- Volunteers
- 5 people
- Sponsor
- Takeda
Substance-related Disorders, Alcohol-Related Disorders
LaunchPad: Supporting Healthy Decisions and Preventing Drug Use After High School
LaunchPad is an online substance use prevention program for high school seniors. The program is designed to help seniors develop skills and make informed decisions as they transition from high school to young adulthood.
- Conditions
- Substance-related Disorders, Alcohol-Related Disorders, Tobacco Use Disorder, Marijuana Use
- Trial name
- NCT07655609
- Testing
- Introduction, Norms re: Protective Behavior Strategies (PBS), Life Skills
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Prevention Strategies, LLC
Substance Use, Stress
Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School
Deviant peer affiliation is one of the most important predictors of alcohol use in adolescence. These affiliations arise when socially marginalized youth self-aggregate and reinforce alcohol use and other deviant activity (i.e.…
- Conditions
- Substance Use, Stress, Relation, Interpersonal, Bullying
- Trial name
- PeerLearning (NCT04478240)
- Testing
- PeerLearning.net
- Where
- United States
- Volunteers
- 924 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Drug Resistance, Bacterial, Antimicrobial Drug Resistance
Fecal Microbiota Transplantation (FMT) to Decolonize Antibiotic - Resistant Bacteria (ARB) - New Protocol
The aim of the study is to assess the safety and efficacy of new protocol fecal microbiota transplantation (FMT) in the eradication of antibiotic resistant bacteria, including those featuring of resistance to new generation…
- Trial name
- STOP-ARB2 (NCT06156956)
- Testing
- Fecal Microbiota Transplantation
- Where
- 5 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Human Biome S.A.
Breast Cancer
LYNPARZA Breast Cancer in the Adjuvant Setting Japan Post-Marketing Surveillance (PMS)
To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual…
- Trial name
- NCT05677308
- Where
- 38 sites in Japan
- Volunteers
- 61 people
- Sponsor
- AstraZeneca
Melanoma, Glioma
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors.
- Conditions
- Melanoma, Glioma, Thyroid Cancer, Non-Small Cell Lung Cancer
- Trial name
- NCT05538130
- Testing
- PF-07799544, PF-07799933
- Where
- 66 sites in United States, Australia and 5 more
- Volunteers
- 148 people
- Sponsor
- Pfizer
Acute Coronary Syndrome, High Bleeding Risk
LEADERS FREE II: BioFreedom™ Pivotal Study
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
- Trial name
- NCT02843633
- Testing
- BioFreedom™ Drug Coated Coronary Stent System, Antiplatelet Drug
- Where
- 66 sites in United States, Canada and 5 more
- Volunteers
- 1,203 people
- Sponsor
- Biosensors Europe SA
Hepatitis C, Chronic, Hepatitis C
Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C.
- Trial name
- NCT00724230
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 505 people
- Sponsor
- Merck Sharp & Dohme LLC
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
Hypertension
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
- Trial name
- NCT01078376
- Testing
- Azilsartan medoxomil (TAK-491)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Takeda
Birth Defects, Pregnancy Complications
UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the…
- Conditions
- Birth Defects, Pregnancy Complications, Epilepsy, Seizures
- Trial name
- NCT00345475
- Where
- United States
- Volunteers
- 516 people
- Sponsor
- UCB Pharma
Prescription Drug Abuse, Substance Abuse
A High School Program for Preventing Prescription Drug Misuse
This project will develop and evaluate a program to prevent prescription drug misuse in high school students
- Conditions
- Prescription Drug Abuse, Substance Abuse, Substance Use (Drugs, Alcohol)
- Trial name
- NCT03219190
- Testing
- LST High School Hybrid
- Where
- United States
- Volunteers
- 1,804 people, healthy volunteers welcome
- Sponsor
- National Health Promotion Associates, Inc.
Oral Neoplasm
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment
The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral…
- Trial name
- NCT04622462
- Testing
- Standard of Care Histopathology, STRATICYTE Assessment
- Where
- 3 sites in Canada
- Volunteers
- 500 people
- Sponsor
- Proteocyte Diagnostics Inc.
Glioblastoma Multiforme
Dendritic Cell Cancer Vaccine for High-grade Glioma
A randomised, open-label, 2-arm, multi-centre, phase II clinical study with one group receiving standard therapy with Temozolomide, radiotherapy, and Trivax; and a control group receiving standard therapy with Temozolomide and…
- Trial name
- GBM-Vax (NCT01213407)
- Testing
- Trivax, Temozolomide, Surgery, Radiotherapy, Temozolomide, Surgery, Radiotherapy
- Where
- 8 sites in Austria
- Volunteers
- 87 people
- Sponsor
- Activartis Biotech
Osteosarcoma
Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma
The purpose of this study was to collect information regarding the safety and tolerability of mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).
- Trial name
- NCT00631631
- Testing
- Mifamurtide (L-MTP-PE)
- Where
- 2 sites in United States
- Volunteers
- 205 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
SCLC, Malignant Melanoma
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA…
- Conditions
- SCLC, Malignant Melanoma, Sarcoma, High Risk Neuroblastoma
- Trial name
- NCT05130255
- Testing
- GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi), GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi), GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- Y-mAbs Therapeutics
COVID-19 SARS-CoV-2 Infection
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease.
- Trial name
- NCT06679140
- Testing
- ibuzatrelvir
- Where
- 256 sites in United States, Argentina and 17 more
- Volunteers
- 2,330 people
- Sponsor
- Pfizer