Phase 1 N=10 Safety of Polyphenon E in Multiple Sclerosis Pilot Study
Multiple Sclerosis
Primary: Number of Participants Experiencing Serious Adverse Events — 0 participants
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Phase 4 N=72 Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)
Myelodysplastic Syndromes · Myeloproliferative Disorders · Leukemia, Lymphocytic
Primary: Non-relapse Mortality — 3; 4; 2 participants — p=.07
Phase 2 N=30 A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients
Human Immunodeficiency Virus 1
Primary: Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%) — -4.8; -0.6 Percentage of brachial artery diameter…
Phase 3 N=480 Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
Type 2 Diabetes Mellitus
Primary: Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 — -0.32; -0.51 Percentage of HbA1c
Phase 2 N=48 Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer
Breast Cancer
Primary: Progression-free Survival (PFS) — 6.6; 3.8 Months — p=0.12
N/A N=40 Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)
Epithelium, Corneal
Primary: Corneal Epithelial Healing Time — 4; 4 days to complete epithelial healing
Phase 4 N=308 Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
Major Depressive Disorder
Primary: CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12 — 57.9; 56.7; 36.4; 35.4 units on a scale
Phase 3 N=142 An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain
Chronic Pain
Primary: Questionnaire of Opioid Withdrawal Symptoms — 137; 2; 1; 0 participants
Phase 3 N=201 Evaluating Improvement Strategies in Addiction Treatment
Addiction
Primary: Change in Average Waiting Time From First Contact to Treatment — .253; 4.610; 4.723; 3.520 Change in days
N/A N=74 Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children
Kerosene Pneumonitis
Primary: Treatment Failure — 3; 2 participants — p=>0.50
Phase 3 N=881 Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
Diphtheria · Tetanus · Pertussis
Primary: Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T — 91.1; 127; 69.2; 127 Titers
Phase 2 N=91 A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
Pain · Diabetic Neuropathies · Neuralgia
Primary: Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 — 6.7; 6.9; -2.6; -2.6 Units on a scale
Phase 3 N=1,169 An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
Multiple Sclerosis
Primary: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate — 0.501; 0.389; 0.319 relapses per year — p=0.0001
Phase 2 N=50 Simvastatin in Preventing a New Breast Cancer in Women at High Risk for a New Breast Cancer
Breast Cancer
Primary: Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline — -0.15; -54; -1; -81.5 mg/dl
Phase 4 N=551 A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
Hepatitis B, Chronic
Primary: Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment — 14.08; 22.86; 25.76; 36.15 Percentage of participants