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NCT ID: NCT02408523 Completed - Epilepsy Clinical Trials

A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications

VALOR
Start date: April 2015
Phase: Phase 3
Study type: Interventional

Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.

NCT ID: NCT02407990 Completed - Advanced Cancer Clinical Trials

Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors

Start date: June 2, 2015
Phase: Phase 1
Study type: Interventional

This study evaluated the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-A317 in participants with advanced tumors.

NCT ID: NCT02407236 Completed - Clinical trials for Inflammatory Bowel Diseases

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

UNIFI
Start date: July 10, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

NCT ID: NCT02407197 Completed - Clinical trials for Coronary Artery Disease

International T1 Multicentre CMR Outcome Study

T1-CMR
Start date: January 2011
Phase:
Study type: Observational [Patient Registry]

Myocardial fibrosis is the fundamental substrate for the development of heart failure. Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial fibrosis based on late gadolinium enhancement (LGE) and T1 mapping. Patients: Prospective longitudinal observational multicenter study of consecutive patients with suspected or known non-ischemic cardiomyopathy. Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume fraction (ECV) and LGE. Primary endpoints: all cause and cardiovascular mortality. Secondary endpoints: arrhythmic composite and HF composite endpoints.

NCT ID: NCT02406989 Completed - Clinical trials for Safety and PK in Healthy Volunteers

A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

Start date: April 2015
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics. Subjects are dosed for 14 days.

NCT ID: NCT02404922 Completed - Healthy Clinical Trials

Multiple Ascending Dose Study in Healthy Volunteers

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.

NCT ID: NCT02401139 Completed - Unipolar Depression Clinical Trials

Ketamine Trial for the Treatment of Depression

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.

NCT ID: NCT02400476 Completed - Clinical trials for Early Stage HER2+ Breast Cancer

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

Start date: February 2015
Phase: Phase 2
Study type: Interventional

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

NCT ID: NCT02399345 Completed - Clinical trials for Chronic Hepatitis C Virus (HCV Infection Genotype 1)

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

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

This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

NCT ID: NCT02397915 Completed - Clinical trials for Rhinitis, Allergic, Perennial and Seasonal

Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays

Start date: March 26, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to provide information on whether subjects with allergic rhinitis (AR) prefer the administration of fluticasone furoate (FF) nasal spray or mometasone furoate (MF) nasal spray based on how the products feel to the subjects when administered. This Phase IV interventional study is a multi-center, randomized, double-blind, single-dose, cross-over subject preference study to evaluate and compare patient preference for FF [(total dose of 110 microgram (mcg)] and MF (total dose of 200 mcg) nasal sprays in subjects with allergic rhinitis. These two commonly used nasal sprays use different actuation systems (FF nasal spray is side-actuated; MF nasal spray is top-actuated) and this study will evaluate whether this difference is reflected in the patient-assessed attributes of the two nasal sprays. The attributes or properties which are being assessed by the subjects for these nasal sprays include smell, taste & aftertaste, drip down the throat, run out of the nose, urge to sneeze, and irritation. The single-day study per subject comprises screening and all treatments and procedures. Eligible subjects will be randomized 1:1 to a cross-over treatment schedule so that all subjects receive both products. One group of subjects will have two sprays of FF administered in each nostril whilst a second group will have two sprays of MF administered into each nostril. At 30 (± 5) minutes after the first study medication treatment, the two groups will switch. The first group will then have two sprays of MF administered into each nostril and the second group will then have two sprays of FF administered into each nostril. After each treatment the subject will complete two sets of attributes questionnaires ('immediate' and 'delayed'). A subject-rated 'immediate' attributes questionnaire will be completed immediately following each treatment and a subject-rated 'delayed' attributes questionnaire will be completed approximately 2 minutes after each treatment. Upon completion of the second set of these two attributes questionnaires (immediate and delayed), a preference questionnaire will be completed by the subject. In the preference questionnaire, the subject states their preferred treatment, if any, for each of the product attributes, and finally states their overall preferred treatment, if any. There will be follow-up contact with the subject 24 (± 4) and 96 (± 4) hours after administration of the last treatment. The study is planned to enroll about 300 subjects.