There are about 7997 clinical studies being (or have been) conducted in Japan. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.
This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.
The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.
The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 patients (150 patients per treatment arm)
The purpose of this study is to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.
The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.
This is a prospective, randomized crossover study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and hypercapnia who require home oxygen therapy (HOT). The total duration of subject participation will be 52 weeks, consisting of 12-week treatment period and 40-week continuation period. Subjects who satisfy all inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy plus HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current HOT. After treatment period, the willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment. The end of the study is defined as the treatment period or continuation period end date of the last participant, whichever is later. Subjects will primarily be assessed by the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24 and 52.
The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice. In addition, this study will describe patient demographics and reason for switching
The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
This is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases falling into specific ICD-10 or International Classification of Diseases, Ninth Revision (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor. For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as the index date. The patient selection period extends from the 1st March 2011 to the 30th June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years age, and ensures approximately 10 months follow-up for living patients recruited at last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth), oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the study (Figure 1). Patients will be identified and followed up through their medical records until death or end of data collection in approximately 20 centers in the US, Asia and Europe. Patients' demographic, clinical characteristics, and medical history will be described. Clinical outcomes including PFS, best response, duration of response, and ORR will be described for the first line and second line of therapy (if any), and OS will be collected A mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has more than one suitable tissue sample, the most recent sample will be used as the mandatory tissue sample. Where available, additional tumor samples obtained at any other time points of the disease will be also collected (optional). The enrolment target is up to 600 patients. Statistical analyses will be performed for the whole cohort, per PD-L1 status and for predefined subgroups.