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.
The purpose of this study in healthy adult males is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594. The purpose of this study in patients with Parkinson's disease is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of KDT-3594 will also be investigated.
To demonstrate the efficacy of dinoprostone vaginal insert (DVI) for cervical ripening success (either bishop score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration
To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration.
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to < 12 years.
The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy. The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.
There are 2 fold of purposes for this study. 1 is to evaluate safety and tolerability and the other is to study the anti-tumor effects of talimogene laherparepvec in Japanese participants with unresectable stage IIIB-IV malignant melanoma.
To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA). Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.
The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).