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NCT ID: NCT03032380 Completed - Clinical trials for Ventilator Associated Pneumonia (VAP)

Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens

APEKS-NP
Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.

NCT ID: NCT02993406 Completed - Clinical trials for Cardiovascular Diseases

Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

CLEAR Outcomes
Start date: December 22, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are statin intolerant.

NCT ID: NCT02989194 Completed - Influenza Clinical Trials

Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A

Start date: January 6, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with uncomplicated influenza.

NCT ID: NCT02979431 Completed - Clinical trials for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Respire
Start date: January 11, 2017
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.

NCT ID: NCT02964949 Completed - Atrial Fibrillation Clinical Trials

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber. Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).

NCT ID: NCT02935608 Completed - Clinical trials for Lumbosacral Radiculopathy

Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy

RELAY-1
Start date: October 31, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.

NCT ID: NCT02931838 Completed - Psoriasis Clinical Trials

Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

Start date: November 15, 2016
Phase: Phase 2
Study type: Interventional

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

NCT ID: NCT02914665 Completed - Heart Failure Clinical Trials

A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

Start date: October 20, 2016
Phase: Phase 2
Study type: Interventional

This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of short term treatment with elamipretide in patients hospitalized with congestion due to heart failure

NCT ID: NCT02914314 Completed - Epilepsy Clinical Trials

Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Start date: February 20, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK) of perampanel during the Maintenance Period of the Core Study following oral suspension administration given as an adjunctive therapy in pediatric participants from 1 month to less than 4 years of age with epilepsy.

NCT ID: NCT02913521 Completed - Clinical trials for Osteoarthritis, Knee

Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%

Start date: June 2015
Phase: Phase 3
Study type: Interventional

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee