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NCT ID: NCT02906020 Terminated - Parkinson's Disease Clinical Trials

A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation

MOVES-PD
Start date: December 15, 2016
Phase: Phase 2
Study type: Interventional

Primary Objectives: - Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other pre-specified variants. - Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in participants with early-stage PD carrying a GBA mutation or other pre-specified variants. Secondary Objectives: Part 1: - To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage PD participants carrying a GBA mutation. - To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage PD participants carrying a GBA mutation. Part 2: - To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage PD participants carrying a GBA mutation as compared to placebo. - To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage PD participants carrying a GBA mutation over a 52-week period.

NCT ID: NCT02905682 Completed - Nocturia Clinical Trials

Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects

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

The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.

NCT ID: NCT02905006 Completed - Clinical trials for Chronic Plaque Psoriasis

Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis

BE ABLE 1
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.

NCT ID: NCT02904902 Completed - Clinical trials for Hidradenitis Suppurativa

Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa

Start date: September 6, 2016
Phase: Phase 3
Study type: Interventional

This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).

NCT ID: NCT02904759 Completed - Nocturia Clinical Trials

Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects

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

The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.

NCT ID: NCT02903420 Active, not recruiting - Aortic Stenosis Clinical Trials

A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)

Start date: September 2016
Phase: N/A
Study type: Interventional

A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

NCT ID: NCT02902978 Completed - Clinical trials for Japanese Healthy Adult Male Participants

A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

Start date: September 26, 2016
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.

NCT ID: NCT02902809 Terminated - Clinical trials for Inadequately Controlled Asthma

A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

Start date: November 11, 2016
Phase: Phase 3
Study type: Interventional

A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist

NCT ID: NCT02901366 Completed - Clinical trials for Healthy Male Subjects

Mass Balance Study of FYU-981

Start date: September 2016
Phase: Phase 2
Study type: Interventional

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.

NCT ID: NCT02900651 Active, not recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

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

The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.