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NCT ID: NCT02563067 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 3, 2015
Phase: Phase 3
Study type: Interventional

This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to 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 (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: NCT02556775 Completed - Clinical trials for Exposure During Pregnancy

Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia

Start date: December 4, 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20 antibodies), regarding the course and outcome of pregnancy in women ever treated with HYQVIA. Development of the fetus/infant at birth and for the first 2 years will also be followed.

NCT ID: NCT02554786 Completed - Asthma Clinical Trials

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

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

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control

NCT ID: NCT02551159 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

KESTREL
Start date: October 15, 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

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: NCT02549001 Completed - Onychomycosis Clinical Trials

Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

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

The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

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.

NCT ID: NCT02540993 Completed - Clinical trials for Chronic Kidney Disease

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

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

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

NCT ID: NCT02540954 Completed - Clinical trials for Macular Degeneration

Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

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

To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

NCT ID: NCT02539368 Completed - Ulcerative Colitis Clinical Trials

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

CONNECT-IBD
Start date: April 22, 2015
Phase:
Study type: Observational

This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade