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NCT ID: NCT02690207 Completed - Herpes Zoster Clinical Trials

Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.

Start date: March 16, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).

NCT ID: NCT02689778 Completed - Clinical trials for Diabetic Nephropathy

Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy

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

It is estimated that approximately 30% of patients with diabetes develop diabetic nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis, control or blocking these mechanisms are therefore potential therapeutical targets for this entity. Current treatment options are based on the glycemic control, blood pressure control, as well as the use of medications such as angiotensin-converting enzyme inhibitors and Angiotensin II receptor antagonists, these actions are not enough to stop progression. Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties. Although the specific mechanism is unknown, pirfenidone interferes with the expression, secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients with type 2 diabetes and nephropathy. The period of time the treatment will be administered will be of 12 months, 62 patients will be included. The primary outcome will be improvement in glomerular filtration rate. The secondary outcomes will be number of patients requiring replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF - β. Change in these parameters will be evaluated at the end of the treatment period (12 months). Throughout the study the incidence of adverse events will be recorded, wich will allow us to learn about the safety and security of the drug in this population.

NCT ID: NCT02684006 Active, not recruiting - Renal Cell Cancer Clinical Trials

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)

Start date: March 23, 2016
Phase: Phase 3
Study type: Interventional

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

NCT ID: NCT02683317 Completed - Clinical trials for Retinopathy of Prematurity

Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Start date: February 22, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.

NCT ID: NCT02683239 Completed - Clinical trials for Osteoarthritis of the Knee or Hip

Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip

FACT LTS & OA
Start date: February 17, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.

NCT ID: NCT02681094 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes

Start date: February 26, 2016
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.

NCT ID: NCT02680574 Completed - Anemia Clinical Trials

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Start date: February 2016
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

NCT ID: NCT02680457 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus

Diabetes
Start date: November 2013
Phase: Phase 4
Study type: Interventional

Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The long-acting insulin has showed to improve glycemic variability however the behavior of insulin glargine versus insulin degludec is unknown.

NCT ID: NCT02678949 Not yet recruiting - Childhood Asthma Clinical Trials

Changes in the Lung Clearance Index in Pediatric Patients With Asthma

Start date: March 2016
Phase: N/A
Study type: Interventional

The multiple breath washout (MBW) is one of pulmonary function test that displays flow and gas concentration plotted against time, and shows an exponential decay in end-tidal gas concentration (washout curve). A number of of indices to describe the washout curve have been proposed, the most commonly reported is the Lung Clearance Index (LCI). This is a simple measure of ventilation heterogeneity derived from MBW, that can be used after challenge with a short action bronchodilator and in response to inhaled steroids, both in the conductive airways as acinar. Patients with moderate and severe asthma are characterized by an abnormality in both, conductive and the acinar airway. Therefore the following research question could be: what are the abnormalities in the heterogeneity of ventilation in children with mild and moderate asthma, with respect to the healthy population measured by MBW, and whether these alterations persist after challenge with inhaled steroids and B2 agonists short-acting.

NCT ID: NCT02675426 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

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Start date: December 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.