Clinical Trial Search

Phase 3 N=404 Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events

Primary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 — 0.27; 3.91; -73.70; -69.98 percent change — p=<0.001

Amgen Results Dec 2015 1.5% serious AE View details

Phase 3 N=164 Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen

Primary Hypercholesterolemia · Mixed Dyslipidemia

Primary: Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8 — 93.9; 91.5 Percentage of participants

Amgen Results Dec 2015 0.6% serious AE View details

Phase 3 N=16 Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants

Primary: Trigger Delay — 35.2; 294.6 ms — p=<0.001

Seoul National University Hospital Results Dec 2015 0.0% serious AE View details

Phase 3 N=307 Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

Hyperlipidemia

Primary: Percent Change From Baseline in LDL-C at Week 12 — -18.08; -15.05; -56.14; -52.60 percent change — p=<0.001

Amgen Results Dec 2015 3.3% serious AE View details

Phase 3 N=1,899 LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

Hyperlipidemia

Primary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 — 9.86; 0.97; -21.96; -17.08 percent change — p=<0.001

Amgen Results Dec 2015 2.0% serious AE View details

Phase 3 N=331 Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

Hyperlipidemia

Primary: Percent Change From Baseline in LDL-C at Week 12 — -2.02; 5.53; -61.25; -55.74 percent change — p=<0.001

Amgen Results Dec 2015 3.7% serious AE View details

Phase 3 N=235 Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

Contact Dermatitis

Primary: Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21 — 78.9 percentage of concordant responses

Allerderm Results Dec 2015 0.0% serious AE View details

Phase 3 N=306 Cediranib, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lung Cancer

Primary: Overall Survival — 12.2; 12.1 months

NCIC Clinical Trials Group Results Dec 2015 39.5% serious AE View details

Phase 3 N=2,341 Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Hypercholesterolemia

Primary: Percentage of Participants Who Experienced Adverse Events (AEs) — 82.5; 81.0; 19.5; 18.7 percentage of participants

Sanofi Results Dec 2015 19.0% serious AE View details

Phase 3 N=178 Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel

Luteal Hormone Supplementation in In-vitro Fertilization · Embryo Transfer

Primary: Clinical Pregnancy Rate Per Embryo Transfer — 28.5 Percentage of pregnancy/embryo transfer

Merck KGaA, Darmstadt, Germany Results Dec 2015 3.4% serious AE View details

Phase 3 N=224 Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)

Acute Myelogenous Leukemia · Acute Lymphocytic Leukemia · Chronic Myelogenous Leukemia

Primary: Percentage of Participants With Overall Survival — 73; 65 percentage of participants — p=0.17

Medical College of Wisconsin Results Dec 2015 8.6% serious AE View details

Phase 3 N=29 Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A

Acquired Hemophilia A

Primary: Percentage of Serious Bleeding Episodes Responsive to OBI-1 — 100 percentage of serious bleeding episodes — p=<0.001

Baxalta now part of Shire Results Dec 2015 44.8% serious AE View details

Phase 3 N=142 An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

Lipid Metabolism, Inborn Errors · Hypercholesterolemia, Autosomal Dominant · Hyperlipidemias

Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) — -28.5; -27; -27.3; -27.9 percent change

Kastle Therapeutics, LLC Results Dec 2015 25.5% serious AE View details

Phase 3 N=509 Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery

Coronary Artery Disease · General Anesthetic Drug Allergy · Coronary Artery Bypass Graft Surgery

Primary: Blood Level of Troponin I — 2.16; 2.57 ng/mL — p=0.02

Air Liquide Santé International Results Dec 2015 15.7% serious AE View details

Phase 3 N=97 A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines

HIV

Primary: Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24) — 196 mcg*hr/mL

National Institute of Allergy and Infectious… Results Dec 2015 20.6% serious AE View details