Clinical Trials Logo

Filter by:
NCT ID: NCT02611830 Completed - Colitis, Ulcerative Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Start date: December 18, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02611817 Completed - Crohn's Disease Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Start date: January 4, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02611778 Completed - Clinical trials for Age-related Macular Degeneration (AMD)

Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

COLUMBUS-AMD
Start date: December 19, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

NCT ID: NCT02611713 Completed - Clinical trials for Advanced Parkinson's Disease

Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease

DUOGLOBE
Start date: January 4, 2016
Phase:
Study type: Observational

This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.

NCT ID: NCT02610777 Completed - Clinical trials for Myelodysplastic Syndromes

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)

Start date: April 14, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.

NCT ID: NCT02610660 Completed - Clinical trials for Hypertension, Pulmonary

Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension

TOPP-2
Start date: August 2015
Phase:
Study type: Observational [Patient Registry]

The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood. Patients will undergo clinical assessments and receive standard medical care, as determined by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically designed to capture the variables that have been proposed as treatment goals in PePH and the reasons for changes in treatment strategy. The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations for children with PH. The registry is planned and implemented under the scientific leadership of the Association for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors. All enrolled patients will have a follow-up period of 18 months.

NCT ID: NCT02610231 Completed - Clinical trials for Idiopathic Parkinson's Disease

Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

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

This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.

NCT ID: NCT02609828 Completed - Cancer Pain Clinical Trials

Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy

Start date: October 28, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether tanezumab is effective in the treatment of cancer pain due to bone metastasis in patients already taking background opioid therapy.

NCT ID: NCT02608034 Completed - Clinical trials for Metastatic Melanoma, BRAF V600 Mutation Positive

A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State

Start date: May 26, 2016
Phase: Phase 1
Study type: Interventional

This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF where the participant has no acceptable standard treatment options.

NCT ID: NCT02607865 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

PIONEER 3
Start date: February 15, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.