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NCT ID: NCT02500706 Completed - Diabetes Clinical Trials

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

onset®8
Start date: May 4, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.

NCT ID: NCT02500641 Completed - Gout Clinical Trials

Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout

FORWARD
Start date: August 17, 2015
Phase: Phase 4
Study type: Interventional

There is a mounting and clear association between hyperuricaemia, gout and the presence of traditional cardiovascular (CV) risk factors and CV event-equivalent conditions such as chronic kidney disease, metabolic syndrome, and diabetes. Gout is associated with increased risk of CV events such as myocardial infarction and CV death. Furthermore hyperuricaemia is clearly associated with an increased arterial stiffness, a marker of pre-clinical atherosclerosis. Carotid-femoral pulse wave velocity (PWV) is the "gold standard" measurement of arterial stiffness and it is considered, in this trial, as a valid surrogate endpoint with clearly established relevance to predict cardiovascular disease (CVD) clinical outcome In this randomised trial conducted on adult subjects with a history of gout, we use surrogate endpoints to investigate the efficacy of febuxostat compared with allopurinol to predict (CVD) clinical outcome. Eligible subjects were randomised in a 1:1 ratio to the following treatment groups: - Test product: febuxostat 80 mg or 120 mg once daily (120 mg daily, if serum urate was >6 mg/dL after 2 weeks of treatment at 80 mg daily). - Active comparator: allopurinol 100 mg once daily (up to a maximum dose of 600 mg daily escalated in 100 mg increments every 2 weeks, if serum urate acid (sUA) was >6 mg/dL after 2 weeks of treatment at the previous dose). The study duration was 39 weeks, which included the: - Run-in/screening period: 1 week (extendable up to a maximum of 30 days according to variability of sUA levels); - Treatment period: 36 weeks; - Safety follow-up period: 2 weeks.

NCT ID: NCT02500381 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD)

ESSENCE
Start date: September 28, 2016
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of SRP-4045 (casimersen) and SRP-4053 (golodirsen) compared to placebo in participants with DMD with out-of-frame deletion mutations amenable to skipping exon 45 and exon 53, respectively.

NCT ID: NCT02499120 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

Start date: September 10, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

NCT ID: NCT02497469 Completed - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

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

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

NCT ID: NCT02497014 Recruiting - Clinical trials for Coronary Artery Disease

The European Bifurcation Club Left Main Study

EBC MAIN
Start date: February 2016
Phase: N/A
Study type: Interventional

The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.

NCT ID: NCT02490514 Completed - Clinical trials for Renal Tubular Acidosis, Distal, With Hemolytic Anemia

A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis

Start date: December 2009
Phase: N/A
Study type: Observational

This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.

NCT ID: NCT02488330 Completed - Solid Tumor Clinical Trials

An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study

Start date: August 27, 2015
Phase: Phase 3
Study type: Interventional

This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.

NCT ID: NCT02486952 Completed - Clinical trials for Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma

MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma

Start date: August 2005
Phase: N/A
Study type: Observational

Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Participants, who were not treated previously for DLBCL, will receive MabThera in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy according to registered indication. Patients will be followed up for safety and efficacy evaluation in accordance with routine practice. The study will be non-interventional and by its design purely observational. All treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.

NCT ID: NCT02480153 Completed - Clinical trials for Rheumatoid Arthritis

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Start date: June 25, 2015
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.