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NCT ID: NCT02576938 Completed - Atopic Dermatitis Clinical Trials

A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis

Start date: February 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.

NCT ID: NCT02576574 Completed - Clinical trials for First Line Non-Small Cell Lung Cancer

Avelumab in First-line NSCLC (JAVELIN Lung 100)

Start date: October 29, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

NCT ID: NCT02576509 Completed - Clinical trials for Hepatocellular Carcinoma

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

Start date: December 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

NCT ID: NCT02576054 Completed - Condyloma Acuminata Clinical Trials

Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

Start date: November 20, 2015
Phase: Phase 3
Study type: Interventional

This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks postdose 3.

NCT ID: NCT02574481 Completed - Clinical trials for Atherosclerosis of Native Arteries of the Extremities

ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

IMPERIAL
Start date: December 2015
Phase: N/A
Study type: Interventional

The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.

NCT ID: NCT02573467 Completed - Clinical trials for Sporadic Inclusion Body Myositis

An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203

Start date: November 2, 2015
Phase: Phase 3
Study type: Interventional

This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit. Due to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased.

NCT ID: NCT02571777 Completed - Asthma Clinical Trials

Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

Start date: December 8, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

NCT ID: NCT02571569 Completed - Hemophilia A Clinical Trials

A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors

Start date: October 28, 2015
Phase: Phase 1
Study type: Interventional

Investigate the safety, tolerability and pharmacokinetics of BAY1093884 after Intravenous (IV) and subcutaneous (SC) administration of increasing single doses and SC administration of multiple doses.

NCT ID: NCT02570035 Completed - Clinical trials for Cardiovascular Disease

Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease

Start date: December 2012
Phase: N/A
Study type: Observational

This purpose of this study is to investigate the effects of mirabegron on the cardiovascular system in patients with overactive bladder with current or a history of cardiovascular disease.

NCT ID: NCT02569242 Completed - Esophageal Cancer Clinical Trials

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Start date: December 14, 2015
Phase: Phase 3
Study type: Interventional

The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.