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NCT ID: NCT02023320 Completed - Prediabetes Clinical Trials

Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.

NCT ID: NCT02021409 Completed - Anemia Clinical Trials

Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934

DIALOGUE 2
Start date: January 28, 2014
Phase: Phase 2
Study type: Interventional

Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin. The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease. The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 15 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests. The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this research.

NCT ID: NCT02021370 Completed - Anemia Clinical Trials

15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)

DIALOGUE 1
Start date: February 10, 2014
Phase: Phase 2
Study type: Interventional

Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin. The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease. The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests. The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.

NCT ID: NCT02020902 Completed - Allergic Rhinitis Clinical Trials

Post Marketing Surveillance for Contac Bien Z in Japan

Start date: March 2013
Phase: N/A
Study type: Observational

This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.

NCT ID: NCT02020889 Completed - Clinical trials for Churg-Strauss Syndrome

A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

Start date: February 5, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.

NCT ID: NCT02019719 Completed - Anaemia Clinical Trials

Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease

Start date: November 5, 2013
Phase: Phase 2
Study type: Interventional

This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD). It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials. This study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a follow-up visit approximately 4 weeks after completing treatment.

NCT ID: NCT02019368 Completed - Clinical trials for Heavy Smoker or Non-smoker

Antioxidant Effect of Aged Garlic Extract

Start date: November 2013
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.

NCT ID: NCT02017860 Completed - Neoplasms Clinical Trials

Study to Collect and Assess Long-term Safety of Everolimus in Patients Who Are on Everolimus Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator.

Start date: January 16, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study was to collect and assess long-term safety of everolimus in patients who were currently receiving everolimus treatment in a Novartis-sponsored, Oncology CD&MA study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol, and were unable to access everolimus treatment outside of a clinical study. Parent studies eligible to participate in the roll-over study were decided by Novartis. Investigator initiated trials (IITs) were not included. The primary objective of the parent study must have been reached and the parent study must have been in the process of being completed and reported.

NCT ID: NCT02016690 Completed - Clinical trials for Respiratory Syncytial Virus Infection

Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immuno Compromised Children With Synagis

Start date: September 2013
Phase: N/A
Study type: Observational

This is a post marketing observational study (PMOS) conducted in Japan in patients receiving palivizumab for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract infection at the age of 24 months and under, who have immunocompromised medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other types of immunodeficiency; HIV infection; recovering from organ or bone marrow transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants) or who have Downs syndrome.

NCT ID: NCT02016183 Completed - Hypertension Clinical Trials

Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)

Start date: April 1, 2009
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD&HD in hypertensive patients in the routine clinical setting