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NCT ID: NCT03219255 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

RELVAR® 100 ELLIPTA® Special Drug Use Investigation (COPD, Long-term)

Start date: August 30, 2017
Phase:
Study type: Observational

This study aims to investigate the long-term safety and efficacy of RELVAR® 100 ELLIPTA® (hereinafter referred to as "Relvar") in daily clinical practice in subjects with chronic obstructive pulmonary disease (COPD), who are naive to RELVAR. A total of 1000 subjects, from approximately 200 medical institutions, will be registered for this study and 332 of them will be considered for safety analysis. In the investigation, subject registration and data collection will be conducted using an Electronic Data Capture (EDC) system. Post-registration, the investigator will monitor the information regarding the safety and efficacy of RELVAR for one year from the start date of treatment with RELVAR. Pneumonia, systemic effects caused by corticosteroids and cardiovascular events will be considered as the priority investigation matters. At the end of observation period, the investigator will enter the obtained information into the EDC system and submit it. RELVAR 100 ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

NCT ID: NCT03218501 Completed - Clinical trials for Uremic Pruritus in Hemodialysis Patients

A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

Start date: August 28, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.

NCT ID: NCT03216902 Completed - Clinical trials for Open-angle Glaucoma, Ocular Hypertension

A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Start date: July 25, 2017
Phase: Phase 2
Study type: Interventional

Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

NCT ID: NCT03214952 Completed - Clinical trials for Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis

Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

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

The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.

NCT ID: NCT03214380 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

PRONTO-T2D
Start date: July 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).

NCT ID: NCT03214367 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study of LY900014 in Participants With Type 1 Diabetes

PRONTO-T1D
Start date: July 17, 2017
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).

NCT ID: NCT03214198 Completed - Clinical trials for A History of Gastric or Duodenal Ulcers

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"

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

The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).

NCT ID: NCT03214094 Completed - Clinical trials for Gastric or Duodenal Ulcers

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

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

The purpose of this survey is to investigate the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

NCT ID: NCT03214081 Completed - Reflux Esophagitis Clinical Trials

Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"

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

The purpose of this survey is to evaluate the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.

NCT ID: NCT03211858 Completed - Clinical trials for Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine

GEMELLI1
Start date: August 2, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®. Secondary Objectives: - To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study. - To assess the relationship of AIAs with efficacy and safety. - To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of participants reaching HbA1c lesser than (<) 7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c). - To assess safety of SAR341402 and NovoLog/NovoRapid.