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NCT ID: NCT01935856 Completed - Hyperparathyroidism Clinical Trials

Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis

NCT ID: NCT01935479 Completed - Osteoporosis Clinical Trials

A Phase I Study of AK159 in Healthy Postmenopausal Women

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.

NCT ID: NCT01934712 Completed - Diabetes Clinical Trials

A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes

Start date: August 30, 2013
Phase: Phase 1
Study type: Interventional

This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.

NCT ID: NCT01934231 Completed - Sinusitis, Acute Clinical Trials

Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis

Start date: August 2013
Phase: Phase 3
Study type: Interventional

Acute Bacterial Rhinosinusitis (ABRS) is a respiratory inflammation commonly seen in clinical practice, which has with respiratory symptoms including nasal congestion, rhinorrhoea, postnasal discharge and cough and is associated with headache, cheek pain, facial pressure and other conditions. The principal bacterial pathogens in causing ABRS include Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. These three bacteria account for approximately 90% of ABRS in children less than or equal to 5 years of age. Combination of Potassium Clavulanate (CVA) and Amoxicillin (AMPC) produces higher antibiotic activity against beta-lactamase-producing bacteria. The present study is designed to assess the clinical efficacy, bacteriological efficacy and safety of CVA/AMPC (1:14) administered in children aged from 3 months to less than 15 years with ABRS. It is an open-label study consisting of a 7-day treatment phase and a post-treatment follow-up phase for 7 to 14 days.

NCT ID: NCT01933958 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Regorafenib Post-marketing Surveillance in Japan

Start date: September 4, 2013
Phase:
Study type: Observational

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice

NCT ID: NCT01933945 Completed - Clinical trials for Carcinoma, Hepatocellular

Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

OPTIMIS
Start date: October 28, 2013
Phase:
Study type: Observational

This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

NCT ID: NCT01933516 Completed - Clinical trials for Indolent B-cell Non-Hodgkin's Lymphoma

GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.

NCT ID: NCT01932372 Completed - Clinical trials for Rheumatoid Arthritis

Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Start date: July 26, 2013
Phase:
Study type: Observational

The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice. 1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2) Long-term safety (particularly, malignant tumors and serious infections) and efficacy Occurrences of malignant tumors and serious infections will be compared with a control group.

NCT ID: NCT01931189 Completed - Healthy Clinical Trials

Pharmacokinetics Study of NI-071

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers

NCT ID: NCT01930188 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

SUSTAIN™ 2
Start date: December 2, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.