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NCT ID: NCT03030339 Completed - Vitamin A Status Clinical Trials

Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children

GloVitAS-P
Start date: August 2016
Phase: N/A
Study type: Observational

The goal of this study is to assess whether children 12-18 months of age who are exposed to multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers of excessive vitamin A status, compared to children 12-18 months of age who have adequate vitamin A intake.

NCT ID: NCT03022097 Completed - COPD Clinical Trials

Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients

AVANT
Start date: January 24, 2017
Phase: Phase 3
Study type: Interventional

This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium bromide compared with Placebo when administered to patients with stable Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT03021499 Completed - Lupus Nephritis Clinical Trials

Aurinia Renal Response in Active Lupus With Voclosporin

AURORA
Start date: May 17, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

NCT ID: NCT03020745 Completed - Hepatitis B Clinical Trials

A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects

Start date: February 14, 2017
Phase: Phase 2
Study type: Interventional

GSK3389404 is being developed for the treatment of CHB virus infection. The development goal for GSK3389404 is the establishment of a finite duration treatment that results in sustained suppression of hepatitis B virus (HBV) replication and viral antigen production after cessation of all treatments for CHB due to the restoration of a functional immune response in the absence of high antigen levels. This study is a multicenter, randomized double-Blind (sponsor un-blinded in Part 1), Placebo-controlled Study which will evaluate the safety, tolerability, PK, and PD profile of GSK3389404 in subjects with CHB and aim to establish proof-of-mechanism. The study will be conducted in two parts. Part 1 plans to enroll subjects primarily from the Asia-pacific region, including Japan and will be conducted as a single ascending dose (SAD) study with 5 planned cohorts ranging from 30 milligram (mg) to a maximum of 240 mg GSK3389404. Within each cohort, subjects will be randomized to receive either GSK3389404 or placebo in a 3:1 ratio. Cohorts A, B, C, C1, and D will be conducted in a sequential fashion; Cohort C1 is an optional cohort and may be dosed after Cohort C or in parallel with Cohort D. Part 2 will be conducted as a multiple-dose, dose-ranging study. Subjects will be randomized to different parallel dose levels and regimens or placebo. The dose levels of Part 2 will be selected after a review of Part 1 safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) data. The treatments selected are 60 mg GSK3389404 weekly, 120 mg GSK3389404 bi-weekly, 120 mg GSK3389404 weekly or placebo. An optional Japanese part-2 sub-study is planned. The total study duration for part 1 including screening, treatment, and post-treatment follow-up, will not be expected to exceed 13 weeks for each subject and for part 2, including screening, treatment and post-treatment follow-up, will not be expected to exceed 65 weeks for each subject.

NCT ID: NCT03020303 Recruiting - Clinical trials for Endstage Renal Disease

Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease

ACHIEVE
Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis. Spironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients. The purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.

NCT ID: NCT03019458 Completed - Clinical trials for X-Linked Dystonia Parkinsonism

MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

MINGO
Start date: February 10, 2017
Phase: N/A
Study type: Interventional

To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen among X-linked Dystonia Parkinsonism patients.

NCT ID: NCT03000959 Recruiting - Acute Stroke Clinical Trials

Stroke Unit in the Philippines: Is it Effective

Start date: April 2016
Phase: N/A
Study type: Observational

This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing the functional outcome between those patient admitted in the general neurology wards and stroke units using modified Rankin Scale

NCT ID: NCT02992418 Terminated - Dengue Fever Clinical Trials

Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects

Start date: December 19, 2016
Phase: Phase 3
Study type: Interventional

The aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or sequentially. Primary Objectives: - To demonstrate the non-inferiority of the humoral immune response to the Tdap booster dose concomitantly administered with the first dose of CYD dengue vaccine as compared to sequential administration, measured 28 days after Tdap booster dose. - To demonstrate the non-inferiority of the humoral immune response to the first dose of CYD dengue vaccine concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the first dose of CYD dengue vaccine. Secondary Objectives: - To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD dengue vaccine with the first dose concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the third dose of CYD dengue vaccine. - To describe the humoral immune response at baseline and 28 days after the first and third doses of CYD dengue vaccine, in each and any group. - To describe the humoral immune response of Tdap vaccine at baseline and 28 days after concomitant administration with the first dose of CYD dengue vaccine as compared to the sequential administration, in each and any group. - To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each and any injection in each group.

NCT ID: NCT02980874 Terminated - Macular Edema Clinical Trials

Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

SAPPHIRE
Start date: January 31, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

NCT ID: NCT02979431 Completed - Clinical trials for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Respire
Start date: January 11, 2017
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.