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NCT ID: NCT02559310 Completed - Clinical trials for Community Acquired Pneumonia

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

LEAP
Start date: September 2015
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.

NCT ID: NCT02555683 Completed - Asthma Clinical Trials

Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

Start date: December 11, 2015
Phase: Phase 3
Study type: Interventional

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: - patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) - patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

NCT ID: NCT02555371 Completed - Asthma Clinical Trials

Cessation Versus Continuation of Long-term Mepolizumab in Severe Eosinophilic Asthma Patients

Start date: January 7, 2016
Phase: Phase 3
Study type: Interventional

Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of mepolizumab treatment will be eligible to participate in this study. This study will be conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8 weeks). During Part A and B subjects will be administered Open-label mepolizumab (100 milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized double-blinded part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks. Subjects discontinuing investigational product (IP) due to a clinically significant asthma exacerbation will then enter optional Part D of the study. During Part D, subjects receive open-label mepolizumab in addition to their standard of care therapy for the remainder of the study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52 weeks after randomization in order to assess subject's efficacy parameters, immunogenicity status, and to conduct additional safety assessments. Eligible subjects will participate in the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks) and Part B (4 to 8 weeks).

NCT ID: NCT02554708 Completed - Clinical trials for Intracranial Aneurysm

pCONus Treatment of Wide Neck Intracranial Aneurysms

pToWin
Start date: August 2015
Phase:
Study type: Observational

To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.

NCT ID: NCT02551224 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive (COPD)

Preference on the Feedback Mechanisms of Dose Delivery Confirmation With the Breezhaler® Device Compared to the Ellipta® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Advantage
Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to compare in COPD patients naïve to DPIs, the perception of the Breezhaler® and Ellipta® devices' feedback mechanisms evaluated using a preference questionnaire.

NCT ID: NCT02550652 Completed - Lupus Nephritis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

Start date: November 13, 2015
Phase: Phase 2
Study type: Interventional

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

NCT ID: NCT02549170 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Start date: December 15, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to learn more about the following treatment options in adults with CIDP: - Subcutaneous self-infusion with HyQvia. - Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound. The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C. The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.

NCT ID: NCT02547922 Completed - Lupus Nephritis Clinical Trials

Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis

TULIP-LN1
Start date: November 4, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).

NCT ID: NCT02546700 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Start date: September 30, 2015
Phase: Phase 2
Study type: Interventional

Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.

NCT ID: NCT02545049 Completed - Clinical trials for Diabetic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

FIGARO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.