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NCT ID: NCT02117791 Completed - Clinical trials for Hypertension, Pulmonary

Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )

JPMS-CTEPH
Start date: July 16, 2014
Phase:
Study type: Observational

This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.

NCT ID: NCT02117258 Completed - Clinical trials for Metastatic Pancreatic Adenocarcinoma

Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

ZIPANG
Start date: April 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma.

NCT ID: NCT02116803 Completed - Solid Tumors Clinical Trials

An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

Start date: May 28, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.

NCT ID: NCT02116569 Completed - Multiple Myeloma Clinical Trials

A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Start date: April 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the tolerability and safety of Daratumumab in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow, characterized by the presence of abnormal proteins in the blood).

NCT ID: NCT02115750 Completed - Clinical trials for Rheumatoid Arthritis

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)

CHS-0214-02
Start date: May 2014
Phase: Phase 3
Study type: Interventional

This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety. Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

NCT ID: NCT02114658 Completed - Thyroid Carcinoma Clinical Trials

Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients

Start date: April 15, 2014
Phase: Phase 2
Study type: Interventional

The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or locally advanced or metastatic medullary thyroid carcinoma (MTC).

NCT ID: NCT02113436 Active, not recruiting - Asthma Clinical Trials

Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma

Start date: May 2014
Phase: Phase 4
Study type: Interventional

This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period. The study is designed to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg one or two BID for 16 weeks. The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in period. The subjects who meet the eligibility criteria for randomization will be stratified according to their age (<2 or >=2 year-old) at Visit 1 and randomized to one of the two treatment groups. The total duration of participation in the study will be 10 weeks for a comparison period completion and 27 weeks for a completion.

NCT ID: NCT02113137 Completed - Halitosis Clinical Trials

Oral Hygiene Procedures on Reduction of Oral Malodor

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.

NCT ID: NCT02113020 Completed - Clinical trials for Clinical Pharmacology

A Phase I Clinical Pharmacology Study of TAK-233 in Healthy Subjects

Start date: February 2014
Phase: Phase 1
Study type: Interventional

The objective of this clinical trial is to examine the clinical pharmacology properties of TAK-233 in healthy female subjects

NCT ID: NCT02111252 Completed - Influenza Clinical Trials

A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants