Phase 1 N=80 Safety Tolerability and Pharmacokinetic of BI 409306
Healthy
Primary: Percentage of Subjects With Drug-related Adverse Events — 0.0; 0.0; 0.0; 33.3 Percentage of subjects
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=30 N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)
GM2 Gangliosidosis · Tay-Sachs Disease · Sandhoff Disease
Primary: Clinical Impression of Change in Severity (CI-CS) [Fields et al 2021] — 0.71 score on a scale — p=0.044
N/A N=219 Bingocize: A Novel Mobile Application for Older Adult Health
Activities of Daily Living · Accidental Fall · Sarcopenia
Primary: Executive Function Inhibition Measure 1: Flanker Task — 7.30; 7.39; 7.38; 7.51 score on a scale
N/A N=282 Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
COVID-19
Primary: Positive Percent Agreement - Sensitivity — 96.2 percent probability
Phase 1 N=40 Safety and Tolerability of BI 409306 in Patients With Schizophrenia
Schizophrenia
Primary: Number of Participants With Drug-related Adverse Events — 1; 3; 2; 3 Participants
N/A N=187 Weight Management in Rural Communities
Weight Loss · Obesity · Body Weight
Primary: Mean Weight Change Over 6 Months — -11.4; -9.1; -2.6 kilograms — p=<.0001
Phase 3 N=60 Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection
Complicated Intra-abdominal Infection
Primary: Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set — 36; 4; 0 Participants
N/A N=864,080 CT DOSE Collaboratory
Ionizing Radiation Exposure · Quality Improvement
Primary: Change in Mean Effective Dose (ED) — -0.13; -0.81; -0.14; -0.26 Millisieverts (mSv)
N/A N=1,021 Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
Parkinson's Disease
Primary: Number of Participants Who Had One or More Adverse Events — 304 Participants
Phase 1 N=24 Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects
Healthy Volunteers
Primary: Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects — 17100…
Phase 1 N=25 Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers
Healthy
Primary: AUC0-infinity of BI 409306 and Its Metabolites — 547; 621; 1560; 1370 nanomole (nmol)*hour (h) /Liter (L)
N/A N=111 Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea
Advanced Renal Cell Carcinoma
Primary: Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) — 92; 79; 14; 7…
Phase 1 N=40 Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306
Healthy
Primary: Percentage of Subjects With Investigator Defined Drug-Related Adverse Events — 50.0; 50.0; 66.7; 50.0 Percentage of subjects
N/A N=4,695 Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19
COVID-19 · Myocardial Reperfusion Injury · Cardiovascular Diseases
Primary: Number of Death — 417; 137; 552 Participants
Phase 3 N=4 Contrast Enhanced Ultrasound in COVID-19
Covid19 · Multisystem Inflammatory Syndrome in Children (MIS-C)
Primary: Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain — 2; 1 Participants