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NCT ID: NCT03345316 Completed - Clinical trials for Children Under 18 Years Old With Kidney Disease

Study of FFI-1010 in Pediatric Kidney Disease

Start date: November 1, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.

NCT ID: NCT03343054 Active, not recruiting - Neoplasms Clinical Trials

A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

Start date: November 30, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part. The dose escalation part is open-label, and evaluates safety, preliminary efficacy and PK of single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available. In the dose escalation part, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed DLTs. The expansion part is designed to assess the efficacy, safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations. In the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary endpoint.

NCT ID: NCT03342963 Completed - Healthy Male Adults Clinical Trials

Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults

Start date: November 21, 2017
Phase: Phase 1
Study type: Interventional

To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1). To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).

NCT ID: NCT03342690 Completed - Clinical trials for Chronic Heart Failure

Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)

Start date: July 5, 2017
Phase:
Study type: Observational

Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice

NCT ID: NCT03341923 Completed - Presbyopia Clinical Trials

Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population

Start date: December 20, 2017
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.

NCT ID: NCT03341871 Completed - Clinical trials for Hepatitis C Virus (HCV)

Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6

Start date: December 27, 2017
Phase:
Study type: Observational

This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.

NCT ID: NCT03340506 Recruiting - Melanoma Clinical Trials

Dabrafenib and/or Trametinib Rollover Study

Start date: December 28, 2017
Phase: Phase 4
Study type: Interventional

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

NCT ID: NCT03340064 Completed - Partial Seizures Clinical Trials

A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age

PEACH
Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.

NCT ID: NCT03339219 Completed - Clinical trials for Advanced Renal Cell Carcinoma

A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Renal Cell Carcinoma

Start date: December 13, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.

NCT ID: NCT03338816 Completed - Clinical trials for Acute Intermittent Porphyria

ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)

Start date: November 16, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).