Phase 3 N=16 Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis
Inborn Errors of Bile Acid Synthesis
Primary: Serum Transaminases — 31.4; 30.9; 62.7; 65.0 U/L
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=41 Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Primary: Treatment-emergent Adverse Events — 41 Number of patients
Phase 3 N=164 Cyclosporine Eye Drops in Preventing Graft-Versus-Host Disease of the Eye in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer or Bone Marrow Failure Disorder
Chronic Myeloproliferative Disorders · Graft Versus Host Disease · Leukemia
Primary: Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo) — 9; 8 participants — p=>0.99
Phase 3 N=283 A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Major Depressive Disorder
Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) — 78.0; 73.1; 71.1 Percentage of participants
Phase 3 N=957 Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
Poliomyelitis
Primary: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value — 456; 456; 456 Participants
Phase 3 N=769 A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
Crohn's Disease · IBD · Colitis
Primary: Number of Participants With Clinical Response at Week 6 — 53; 84; 84 participants — p=0.002
Phase 3 N=89 Implantable Cardioverter-Defibrillator Use in the VA System
Cardiomyopathies
Primary: Referral for Implantable Cardioverter Defibrillator — 11; 1 participants
Phase 3 N=300 A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes
Diabetes Mellitus, Type 2
Primary: Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) — -1.44; -0.67 percentage of change — p=<.001
Phase 3 N=248 Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Menopause · Osteoporosis · Osteopenia
Primary: Change From Baseline in Bone Mineral Density — 1.146; 1.132 g/cm2
Phase 3 N=10 Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Cystic Fibrosis
Primary: Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1 — 15200; 1920 nanogram per milliliter (ng/mL)
Phase 3 N=150 TRIAD - Treatment of Insomnia and Depression
Sleep Initiation and Maintenance Disorders · Depression
Primary: Percent of Participants With Depression Remission — 36.0; 43.8 percentage of participants in arm
Phase 3 N=41 Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Scleroderma, Systemic · Scleroderma, Diffuse · Scleroderma, Limited
Primary: Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus — 260.0; 246.3 perfusion units
Phase 3 N=108 Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy
Epilepsy
Primary: Adverse Events — 126; 26 Number of adverse events
Phase 3 N=66 BAX 855 Pediatric Study
Hemophilia A
Primary: Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII) — 0; 0; 0 participants
Phase 3 N=147 Darbepoetin Alfa in Patients With Anemic Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
MDS
Primary: Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period — 59.2; 36.1 percentage of participants — p=0.008