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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: 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: 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.

NCT ID: NCT02822742 Completed - Clinical trials for Primary Open Angle Glaucoma or Ocular Hypertension

A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study

Start date: July 2, 2016
Phase: Phase 3
Study type: Interventional

The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.

NCT ID: NCT02822729 Completed - Clinical trials for Open Angle Glaucoma or Ocular Hypertension

A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study

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

The purposes of this study are to evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle glaucoma or ocular hypertension.

NCT ID: NCT02821052 Completed - Diabetes Clinical Trials

Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®

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

This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

NCT ID: NCT02820844 Completed - Clinical trials for Urinary Bladder, Overactive

Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder

Start date: August 10, 2016
Phase: Phase 3
Study type: Interventional

GSK1358820 is a botulinum neurotoxin A complex that has been approved for the treatment of overactive bladder (OAB) in several countries, however, it has not been approved for OAB treatment in Japan. This study has been planned to evaluate the efficacy and safety of GSK1358820 in Japanese OAB patients with urinary incontinence whose symptoms have not been adequately managed with other medications for OAB. The primary objective of this study is to evaluate the superiority of a single dose treatment of GSK1358820 100 units (U) compared with placebo. The study comprises a screening phase up to 28 days, followed by a double-blind treatment phase of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820 100 U injection or Placebo injection, in a ratio of 1:1, with further stratification within the treatment arms according to the number of urinary urge incontinence episodes during screening. Subjects meeting the criteria for re-treatment will receive a second and third treatment. Each re-treatment will be with open-label GSK1358820 100 U injection, and will be spaced at least 12 weeks from the previous treatment. The total duration of participation for any subject will not exceed 52 weeks, including screening and the 48-week treatment period.

NCT ID: NCT02819635 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: September 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.