Phase 1 N=7 Pharmacodynamic Evaluation of Intranasal Nalmefene
Pharmacodynamic
Primary: Change in Minute Ventilation — 3.432; 5.744 L/min — p=<0.0009
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=23 Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease
Stargardt Disease · Macular Atrophy
Primary: Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram — -12.23; 68.00; 96.69 percent suppression
Phase 1 N=36 Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
Healthy
Primary: Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) — 281.05; 485.48; 410.46 ng*h/mL
Phase 2 N=100 Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
Hypertriglyceridemia
Primary: Percent Change in Plasma Triglycerides (Pharmacodynamic Population) — -20.9; -18.3 Percent Change from baseline
Phase 4 N=65 A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients Undergoing PCI With CYP2C19 Loss-of-function:
Coronary Artery Disease
Primary: Platelet Reactivity — 36; 33 PRU
Phase 1 N=23 Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: Change in Clearance of Sodium, Potassium, Creatinine, Magnesium, Chloride,Calcium, Phosphate and Uric Acid From Baseline — -0.031; -0.055; -0.071; 0.143 ml/min
Phase 4 N=82 Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies
Coronary Artery Disease · Peripheral Arterial Disease · Atrial Fibrillation
Primary: Platelet-Mediated Global Thrombogenicity — 66; 59; 69; 71 percentage of aggregation — p=0.275
Phase 2 N=59 Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
Intubated and Mechanically Ventilated Pediatric Subjects
Primary: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) — 2681.332; 6460.576; 16992.540; 28531.864 picograms*hr/mL
Phase 4 N=34 A Pharmacodynamic Study With Ticagrelor in African American Patients
Stable Coronary Artery Disease
Primary: Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading…
Phase 4 N=40 A Pharmacodynamic Study With Ticagrelor in Hispanic Patients
Stable Coronary Artery Disease
Primary: Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading…
Phase 1 N=20 A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Primary: Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose — 0.92; 0.98 h*nmol/L — p=0.02
N/A N=110 Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
Coronary Artery Disease
Primary: Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) — 32.1; 32.6 PRI%
Phase 1 N=72 Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors
Healthy Subjects · Pharmacokinetics · Pharmacodynamics
Primary: Baseline-adjusted Area Under Effect Curve (AUEC) for LDL-C for Evolocumab and Alirocumab — -380; -754; -866; -1832 mg/dL*day
N/A N=82 Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor
Coronary Artery Disease · Acute Coronary Syndrome
Primary: Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay — 45; 63 PRU
Phase 1 N=11 Prescription Medication Interactions
Opioid Use · Sedative Use
Primary: Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking — 7.40; 39.00; 40.80; 24.50 Score on a scale — p=<0.0001
Phase 4 N=110 Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease
Coronary Artery Disease
Primary: P2Y12 Reaction Units — 95.0; 49.0 PRU (P2Y12 Reaction Units)
Phase 1 N=30 Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
Epilepsy
Primary: Maximum Drug Concentration (Cmax) — 9469; 9867; 15067; 17309 ng/mL
Phase 4 N=77 Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI
Coronary Artery Disease · Acute Coronary Syndrome
Primary: Platelet Reactivity Measured by VerifyNow — 23; 153; 65 PRU
Phase 2 N=20 Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects
Reflux
Primary: Reflux Episodes 0 to 3 Hours Post Meal — 15.1; 12.5; 11.0; 12.7 Episodes
N/A N=50 Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes
Diabetes Mellitus · Coronary Artery Disease
Primary: P2Y12 Reaction Units — 83; 52 PRU — p=0.022
Phase 1 N=77 Pharmacodynamic Study of Cilostazol in Healthy Volunteers
Healthy
Primary: Ex-vivo Inhibition Of Platelet Aggregation (IPA) — 0.82; 1.21; 1.03; 4.42 ratio
N/A N=35 Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy
Coronary Artery Disease
Primary: TRAP-induced Platelet Aggregation — 74; 77 percentage of aggregation — p=<0.05
N/A N=60 Propofol Pharmacokinetics and Pharmacodynamics Modelling
Intravenous Anesthetic Agent Overdose
Primary: Plasma Propofol Concentration (mcg/mL) — 2.36; 3.12; 2.91 mcg/mL
Phase 2 N=37 Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199
Asthma · Airway Obstruction
Primary: FEV1 Peak Effect Within 0 - 24 h Post-dose — 3.56; 3.62; 3.70; 3.62 L
N/A N=60 In Vitro Pharmacodynamic Effects of Cangrelor in Ticagrelor Treated Patients
Coronary Artery Disease
Primary: Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP) — 30; 30; 18; 17 %PRI
Phase 2 N=59 Pharmacokinetics of Advantage Arrest in Children
Dental Caries
Primary: Predicted Peak Serum Silver Concentration (Cmax) — 17.8 ng/ml
N/A N=107 Pharmacokinetics of Daunorubicin in Young Patients With Cancer
Unspecified Childhood Solid Tumor, Protocol Specific
Primary: Population Estimates for Daunorubicin Hydrochloride Clearance — 116 L/m2/hr
Phase 3 N=41 The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
Cardiac Transplant · Patent Ductus Arterious · Atrial Septal Defect
Primary: Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine. — -0.14; -0.16; -0.21; 0.15 percentage of change from baseline — p=0.05
Phase 2 N=66 Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Healthy Volunteers · Brain Lesion
Primary: Pharmacokinetic (PK) Parameter Cmax — 248.7; 524.5; 698.7; 992.0 µg/mL
Phase 1 N=72 Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists
Healthy Subjects · Pharmacokinetics · Pharmacodynamics
Primary: Area Under Effect Curve (AUEC) for Eosinophils for Mepolizumab and Reslizumab — -1804; -195; -1456; -1428 Percentage change from baseline * day