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NCT ID: NCT02828917 Completed - Clinical trials for de Novo or Restenosis Lesions

MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)

JNIR
Start date: January 16, 2017
Phase: N/A
Study type: Interventional

MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: - A mounted Cobalt Chromium (CoCr) alloy based stent - A Rapid Exchange (RX) Coronary System Delivery System - A Poly n-butyl methacrylate (PBMA) and CarboSil®Polymer matrix coating - Ridaforolimus drug - CAS Registry Number: 572924-54-0 MedJ-01 is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions. JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient population to show equivalence to the results of the BIONICS Trial.

NCT ID: NCT02828319 Completed - Clinical trials for Iron Deficiency Anemia

Clinical Study of Z-213 in Subjects With Iron-deficiency Anemia

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

To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213 administration in patients with iron deficiency Anemia

NCT ID: NCT02828254 Completed - Clinical trials for Hepatitis C Virus-infected Cirrhosis

A Follow-up Evaluation Study of PRI-724-1101

Start date: December 18, 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up.

NCT ID: NCT02827942 Completed - Clinical trials for Gastritis Associated With Helicobacter Pylori

Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication

Start date: July 1, 2016
Phase: Phase 3
Study type: Interventional

Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1 week. Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.

NCT ID: NCT02826863 Recruiting - Dravet Syndrome Clinical Trials

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

Start date: July 15, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Subjects who qualify for the study will be randomized (1:1:1) in a double-blind manner to receive 1 of 2 doses of ZX008 or placebo. All subjects will be titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects will continue treatment at their randomly assigned dose over a 12-week Maintenance Period. Total treatment time from the beginning of the Titration Period through the end of the Maintenance Period is 14 weeks.

NCT ID: NCT02825160 Completed - Clinical trials for Hypertension, Pulmonary

Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)

Start date: August 1, 2016
Phase:
Study type: Observational

This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH

NCT ID: NCT02824432 Completed - Hyperlipidemia Clinical Trials

Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation

Oasis Flow
Start date: August 4, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.

NCT ID: NCT02824094 No longer available - Neoplasms Clinical Trials

Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

Start date: n/a
Phase: N/A
Study type: Expanded Access

Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.

NCT ID: NCT02823145 Completed - Dravet Syndrome Clinical Trials

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome

Start date: June 8, 2016
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.

NCT ID: NCT02822794 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

Start date: July 25, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.