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NCT ID: NCT02670915 Completed - Diabetes Clinical Trials

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

onset®7
Start date: May 4, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.

NCT ID: NCT02670538 Completed - Depression Clinical Trials

Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder

Start date: March 31, 2016
Phase: Phase 3
Study type: Interventional

This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

NCT ID: NCT02670330 Terminated - Clinical trials for Epidermolysis Bullosa

Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa

Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

NCT ID: NCT02669758 Completed - Schizophrenia Clinical Trials

A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Start date: January 20, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

NCT ID: NCT02668653 Completed - Leukemia Clinical Trials

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

QuANTUM-First
Start date: September 1, 2016
Phase: Phase 3
Study type: Interventional

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

NCT ID: NCT02665845 Completed - Ulcerative Colitis Clinical Trials

Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).

COMBOMESA
Start date: June 13, 2016
Phase: Phase 3
Study type: Interventional

The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation. The aim of this study is to compare the efficacy of steroids alone vs. combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

NCT ID: NCT02654678 Not yet recruiting - Heart Failure Clinical Trials

Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril

LENA-WP10
Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12 years of age at recruitment into the preceding short-term pharmacokinetic (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as acceptability and palatability assessments in children still under enalapril Orodispersible Minitablet (ODMT) treatment.

NCT ID: NCT02652741 Not yet recruiting - Heart Failure Clinical Trials

Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease

LENA-WP09
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

NCT ID: NCT02652728 Not yet recruiting - Heart Failure Clinical Trials

Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy

LENA-WP08
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age, suffering from heart failure due to dilated cardiomyopathy, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

NCT ID: NCT02647866 Completed - Ulcerative Colitis Clinical Trials

Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

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

The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.