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NCT ID: NCT03844945 Completed - Ocular Hypertension Clinical Trials

Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

Start date: March 19, 2019
Phase: Phase 2
Study type: Interventional

Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan

NCT ID: NCT03840174 Completed - Clinical trials for Cytomegalovirus Infections

Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)

Start date: March 8, 2019
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis.

NCT ID: NCT03837704 Completed - Smoking Clinical Trials

Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS, Continue Smoking, or Quit Smoking.

Start date: October 3, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the reduction of the Abdominal Aortic Aneurysm (AAA) annual growth rate in patients who switch from smoking cigarettes to using IQOS as compared to patients who continue to smoke cigarettes. The study also aims to provide context to the scale of reduction in the growth rate, by comparing the AAA annual growth rates for continuing to smoke and switching to IQOS with the AAA annual growth rate in smokers who had stopped smoking. The study will further evaluate the effects of switching to IQOS on co-morbidities observed in AAA patients that are related to smoking as well as to assess the effects on relevant clinical risk endpoints linked to smoking related diseases.

NCT ID: NCT03837184 Completed - Clinical trials for Spinal Muscular Atrophy Type I

Single-Dose Gene Replacement Therapy Using for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies

Start date: May 31, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in participants with spinal muscular atrophy (SMA) Type 1 and who are genetically defined by a biallelic pathogenic mutation of the survival motor neuron 1 gene (SMN1) with one or two copies of survival motor neuron 2 gene (SMN2). The primary objective of the study is to evaluate the efficacy of onasemnogene abeparvovec-xioi by assessing the proportion of symptomatic SMA Type 1 participants who achieve the ability to sit unaided for at least 10 seconds up to and including the 18 months of age trial visit. At least 6 participants aged < 6 months (< 180 days) at the time of gene replacement therapy (Day 1) will be enrolled.

NCT ID: NCT03834519 Completed - Prostatic Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)

KEYLYNK-010
Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected.

NCT ID: NCT03834506 Completed - Prostatic Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

NCT ID: NCT03833661 Completed - Cholangiocarcinoma Clinical Trials

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

Start date: March 26, 2019
Phase: Phase 2
Study type: Interventional

The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.

NCT ID: NCT03831607 Completed - Hyperphosphatemia Clinical Trials

A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD

Start date: December 27, 2018
Phase: Phase 2
Study type: Interventional

To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD.

NCT ID: NCT03830866 Completed - Clinical trials for Locally Advanced Cervical Cancer

Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)

CALLA
Start date: February 15, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer

NCT ID: NCT03830528 Completed - Parkinson's Disease Clinical Trials

A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects

Start date: February 26, 2019
Phase: Phase 1
Study type: Interventional

Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers