Matsudo

This research aims to evaluate how well and safely orforglipron works in adult female participants with stress urinary incontinence SUI who also have obesity or are overweight. SUI is a condition where urine leaks during activities such as coughing or exercising. The study is a Phase 3 clinical trial conducted under a master protocol supporting two independent studies, focusing on this specific population. Participants will be randomly assigned to receive either orforglipron or a placebo, both given orally once daily. The study uses a double-blind design with parallel groups to compare the effects of orforglipron against placebo. The treatment period lasts approximately 52 weeks, followed by safety follow-up, making total participation about 58 weeks from screening to study completion. During the study, participants will undergo assessments including measuring changes in the frequency of incontinence episodes, body weight, quality of life related to urinary incontinence, use of continence pads, and cholesterol levels. Researchers will monitor waist circumference and patient impressions of their condition as well. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Researchers are evaluating the efficacy and safety of a combination of KarXT and KarX-EC to treat cognitive impairment in individuals with mild to moderate Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to understand how these treatments affect thinking and memory problems associated with Alzheimers. The study is sponsored by Bristol-Myers Squibb and focuses on participants aged 60 to 85 years diagnosed according to specific clinical criteria and biomarkers. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. The medications are given at specified doses on designated days, though exact dosing schedules are not detailed in the summary. The study follows a parallel-group design, comparing the effects of the active drugs against placebo over a treatment period lasting 24 weeks. During the study, participants and their caregivers will attend visits where cognitive function and daily living abilities are assessed using tools such as the Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog11 and Clinicians Interview-Based Impression Plus Caregiver Input CIBIC. Safety is closely monitored through reports of adverse events, vital signs, laboratory tests, ECGs, and other clinical evaluations. The study lasts through the treatment period up to 24 weeks, with continuous monitoring of participant health and cognitive changes.

This research aims to learn about the safety and effects of the study medicine PF-07328948 for adults with heart failure. The study evaluates whether PF-07328948 is safe and effective compared to a placebo in people who already take standard heart failure medicines including SGLT2 inhibitors. It is a phase 2 randomized, double-blind, placebo-controlled trial sponsored by Pfizer. Participants will take either placebo tablets or one of three doses of PF-07328948 tablets once daily by mouth for 36 weeks. The study includes four groups placebo, low dose, medium dose, and high dose of PF-07328948. Treatment lasts 36 weeks, followed by monitoring and assessments. Participants will be involved for about 48 weeks with 15 visits to the study clinic, of which 5 may be performed at home by phone and 10 in person. Researchers will assess clinical events, 6-minute walk test distance, and heart failure symptom scores at baseline and week 36. Safety will be monitored through adverse event reporting up to week 40. Various questionnaires and physical tests will track health status and treatment effects throughout the study.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the effect and safety of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease PAD who experience symptoms such as intermittent claudication. This phase 3 trial aims to understand how the drug affects walking ability and symptom relief over a period of about 58 weeks. The study is sponsored by Eli Lilly and Company and involves participants with confirmed PAD and reduced ankle brachial index ABI. Participants are randomly assigned to receive either orforglipron or a placebo in a double-blind design. Participants will take the study drug or placebo orally once daily. The study includes two groups one receiving orforglipron, and the other receiving a placebo. The treatment period lasts for approximately 52 weeks, during which participants will be monitored closely. This design allows comparison of the drugs effects against placebo on walking distance, symptoms, and quality of life measures. During the study, participants will undergo assessments including measuring their maximum walking distance, pain-free walking distance, and performance in a six-minute walk test at baseline and after 52 weeks. Questionnaires evaluating vascular quality of life and blood tests measuring inflammatory markers and blood pressure will also be collected. Safety and symptom relief will be monitored throughout the nearly one-year participation, helping to determine the drugs impact on PAD symptoms and overall vascular health.

Researchers are evaluating surgical aortic valve replacement SAVR compared to transcatheter aortic valve replacement TAVR in patients with isolated severe, calcific aortic stenosis who are at low surgical risk. This study, called the AMETHYST trial, aims to determine if SAVR is not worse than TAVR regarding death, stroke, and rehospitalization one year after the procedure. The study is randomized, controlled, and conducted at multiple centers. Participants will be randomly assigned to either receive SAVR, where the surgeon chooses the type of surgical bioprosthetic valve and surgical method, or TAVR, which uses approved transcatheter heart valves available in Japan. The treatments will be delivered according to the assigned group, and patients will be followed for up to 10 years with visits at discharge, 30 days, and annually. During the study, participants will undergo assessments including survival, stroke occurrence, rehospitalization related to valve or heart failure, and heart rhythm changes. Researchers will also evaluate valve function using echocardiography and quality of life through questionnaires at one year. Safety monitoring continues through the long follow-up period. The primary outcome combines death from any cause, stroke, and rehospitalization at one year post-procedure.

Researchers are evaluating the safety and effectiveness of the Double-effect kissing balloon technique W-KBT using Perfusion balloon PB and Drug coated balloon DCB in patients with left main coronary artery disease LMD who have left circumflex artery LCx ostium stenosis. This prospective, observational, multi-center study focuses on patients with stable angina, non-ST-elevation myocardial infarction, or unstable angina who require percutaneous coronary intervention PCI. Patients who meet the selection criteria will receive PCI with W-KBT following crossover stenting for LMT-LAD direction, proximal optimization technique POT, and conventional kissing balloon technique C-KBT as part of usual care. Approximately 280 participants aged 18 and older will be enrolled across 17 sites in Japan. The study will monitor patients through hospital discharge and for 12 months afterward during routine clinical practice. Participants will be followed to assess procedure success during PCI and major adverse cardiovascular events MACE within 12 months. Additional measures include time to ST-change from DCB inflation, total DCB inflation time, changes in blood pressure and heart rate, use of vasopressors or mechanical support after W-KBT, and incidence of ischemia-driven revascularization at the LCx ostium. Data will be collected to evaluate the efficacy and safety of this treatment approach over the year following the procedure.

Researchers are evaluating two different approaches to antithrombotic therapy after Left Atrial Appendage Closure LAAC in people with non-valvular atrial fibrillation who have a high risk of bleeding. The study compares Non-Antithrombotic Therapy NAPT followed by oral anticoagulants OAC monotherapy for 45 days against Single Antiplatelet Therapy SAPT with aspirin. This Phase 4 trial aims to determine if the NAPT approach is not worse than SAPT over an observation period of up to 4 years, focusing on a combination of serious events including death, heart attack, stroke, embolism, and bleeding complications. Participants are randomly assigned to one of two groups the SAPT arm or the NAPT arm, with equal chance of assignment. Both groups start with oral anticoagulants for 45 days after LAAC. After this period, the SAPT group continues with low-dose aspirin, while the NAPT group does not receive further antithrombotic medication for the remainder of the study. The study includes visits at 45 days, 1 year, and 2 years after enrollment, along with telephone follow-ups up to 4 years. During their participation, subjects will undergo clinical evaluations to monitor safety and effectiveness, including imaging tests to check for device-related thrombus at specific intervals. Researchers will track major health events such as mortality, heart attacks, strokes, embolism, and bleeding incidents throughout the study. The study includes regular hospital visits, phone assessments, and ongoing observation, lasting up to 4 years per participant to thoroughly assess long-term outcomes.