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NCT ID: NCT02583451 Completed - Clinical trials for Healthy Participants

Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects

Start date: November 2015
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance

NCT ID: NCT02580591 Completed - Clinical trials for Diabetes Mellitus, Type 1

Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

Start date: December 22, 2015
Phase: Phase 3
Study type: Interventional

The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin

NCT ID: NCT02580513 Completed - Clinical trials for Diabetes Mellitus, Type 2

Circadian Misalignment and Insulin Sensitivity

Start date: January 2016
Phase: N/A
Study type: Interventional

This study will evaluate the effect of circadian misalignment on insulin sensitivity in healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the research facility for two study periods of 3 and 3.5 days. In one of the study periods, the behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a hyperinsulinemic euglycemic clamp.

NCT ID: NCT02580058 Completed - Ovarian Cancer Clinical Trials

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

Start date: December 21, 2015
Phase: Phase 3
Study type: Interventional

A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.

NCT ID: NCT02579759 Completed - Clinical trials for Charcot-Marie-Tooth Disease Type 1A

Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT)

PLEO-CMT
Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether PXT3003 is effective and safe in the treatment of Charcot-Marie-Tooth disease - Type 1 A (CMT1A). This double-blind study will assess in parallel groups 2 doses of PXT3003 compared to Placebo in CMT1A patients treated for 15 months.

NCT ID: NCT02579603 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF

Start date: October 16, 2015
Phase: Phase 4
Study type: Interventional

This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone. A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.

NCT ID: NCT02578797 Completed - Clinical trials for Castration-Resistant Prostate Cancer

A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study

Start date: December 18, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether daily treatment with apalutamide affects the ventricular repolarization in participants with Castration-Resistant Prostate Cancer (CRPC)

NCT ID: NCT02578550 Completed - Healthy Clinical Trials

A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants

Start date: November 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the single-dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC) (D/C/F/TAF) relative to the separate agents (DRV 800 mg tablet formulation and FTC/TAF 200/10 mg FDC) in the presence of 150 mg Cobicistat (COBI), under fed conditions, in healthy participants.

NCT ID: NCT02578472 Completed - Healthy Clinical Trials

Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Participants

Start date: November 2015
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at 2, 4, 6 and 8 hours post-evening dose.

NCT ID: NCT02578446 Active, not recruiting - Arthroplasty Clinical Trials

Uncemented Tritanium Compared With Cemented Metal-backed Tibia Components in Total Knee Replacement

Start date: October 2015
Phase: N/A
Study type: Interventional

The optimal method of total knee replacement component fixation to the bone remains a challenge. The use of bone cement is considered the gold standard and is the preferred technique for most surgeons. However, uncemented fixation methods have been developed in an attempt to tackle problems that can be seen when cement is used. The cement-bone interlock can deform and degrade over the years and can lead to aseptic loosening, especially in young and active patients. A loosened prosthesis results in an impaired functioning and painful knee in daily life for which a revision of the prosthesis may be necessary. To prevent aseptic loosening and subsequent revision surgery, new methods of uncemented fixation have been developed. One of these methods is to use a highly porous metal called Tritanium®. It can improve the biologic fixation by resembling the characteristics of trabecular bone. It is expected that this surface aids bone ingrowth and to have similar or even better results concerning early fixation properties and long-term durability compared with cemented fixation. Excellent results using this highly porous Tritanium have been seen in total hip surgery already. This single-blinded, randomized clinical trial will assess clinical and radiological outcomes including Roentgen Stereophotogrammetry (RSA) measurements of a newly approved uncemented Triathlon Tritanium CR total knee prosthesis compared with a standard cemented Triathlon metal-backed CR total knee prosthesis (both by Stryker Orthopaedics). Two arms of each 35 patients will be included. The primary outcome measure will be prosthetic migration after two years of the uncemented Triathlon Tritanium CR Total Knee and the cemented Triathlon CR Total Knee by means of RSA. It is hypothesized that the new uncemented Tritanium prosthesis will perform at least equally good in terms of migration and clinical parameters compared with the standard cemented Triathlon. The secondary outcome measure will be long-term (10-year) survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year results will be used to verify the predicted long-term survival results.