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NCT ID: NCT02912533 Completed - Anemia Clinical Trials

A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

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

The purpose of this study is to investigate the safety and efficacy for 52-week dosing of JR-131 in renal anemia patients with chronic kidney disease (CKD).

NCT ID: NCT02912494 Completed - Anemia Clinical Trials

A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

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

The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).

NCT ID: NCT02911948 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs

DUALâ„¢ II Japan
Start date: September 21, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide and insulin degludec both in combination with metformin in Japanese subjects with type 2 diabetes mellitus inadequately controlled with basal or pre-mix/combination insulin therapy and oral anti-diabetic drugs.

NCT ID: NCT02911857 Completed - Clinical trials for Periodic Fevers Syndrome

An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes

Start date: October 3, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.

NCT ID: NCT02908685 Completed - Clinical trials for Muscular Atrophy, Spinal

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants

SUNFISH
Start date: October 19, 2016
Phase: Phase 2
Study type: Interventional

Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.

NCT ID: NCT02907359 Completed - Clinical trials for Myelodysplastic Syndromes

Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs

Start date: January 13, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.

NCT ID: NCT02907229 Completed - Clinical trials for Intracranial Aneurysm

Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms

NCVC-CS1_UAN
Start date: May 2016
Phase: N/A
Study type: Interventional

This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of intracranial aneurysms which are difficult to be cured by conventional surgical or endovascular procedures.

NCT ID: NCT02907216 Completed - Rotavirus Clinical Trials

Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants

Start date: September 16, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since 2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been evaluated during the clinical development of the HRV vaccine, the vaccine differed in composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when co-administered with the liquid HRV vaccine

NCT ID: NCT02906930 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

PIONEER 1
Start date: September 20, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.

NCT ID: NCT02906683 Completed - Clinical trials for Stress Urinary Incontinence

Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

Start date: October 1, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.