Phase 3 N=145 RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
Liver Transplantation
Primary: Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl) — 0.99; 2.26 mL/min
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=108 Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
Back Pain
Primary: Sum of Pain Intensity Difference Over 3 Days (SPID72) — 139.0; 129.4; 114.2 Scores on a scale
Phase 3 N=336 Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Menopause · Postmenopausal Vaginal Atrophy
Primary: Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies — 0; 0; 0; 0 percentage of participants
Phase 3 N=795 A Study for Patients With Head and Neck Cancer
Head and Neck Neoplasms
Primary: Overall Survival (OS) — 7.33; 6.28 Months — p=0.082
Phase 3 N=313 Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Thrombocytopenia · Idiopathic Thrombocytopenic Purpura
Primary: Number of Participants With Adverse Events — 284; 19 Participants
Phase 3 N=409 Generalized Anxiety Disorder Adjunct Study
Anxiety · Anxiety Disorders · Anxiety Neuroses
Primary: Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score — -10.74; -9.61 units on scale
Phase 3 N=25 Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
Juvenile Rheumatoid Arthritis
Primary: Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 — 23 Participants
Phase 3 N=518 Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Primary: Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8 — 16.5; 9.3 Percentage of Participants — p=0.019
Phase 3 N=258 A Long-term Study for the Treatment of Painful Diabetic Neuropathy
Diabetic Neuropathies
Primary: Number of Participants Who Experienced an Adverse Event (AE) — 11; 22; 126; 121 participants
Phase 3 N=317 A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.
Macular Edema Associated With Diabetes Mellitus
Primary: Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year — 49; 25 Participants — p=0.0047
Phase 3 N=817 Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
Leukemia
Primary: Progression-free Survival (PFS) — 981.0; 1212.0 Days — p=<.0001
Phase 3 N=30 A Study to Assess the Safety of Adacel® Vaccine
Diphtheria · Tetanus · Pertussis
Primary: Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine — 27; 27; 0; 1 Participants
Phase 3 N=269 Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
ADHD
Primary: Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up…
Phase 3 N=789 Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
Primary Insomnia
Primary: The Change From Baseline in Subjective Sleep Latency. — -19.1; -1.7 minutes — p=<0.05
Phase 3 N=85 Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Neuroendocrine Tumors
Primary: Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) — 14.3; 6.0 Months