Miyakonojo

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating how well vortioxetine, given at doses of 10 mg or 20 mg per day, works compared to a placebo to treat depression symptoms in Japanese teenagers aged 12 to 17 years diagnosed with Major Depressive Disorder MDD. The study focuses on assessing both the effectiveness and side effects of vortioxetine in this young population. Participants will take the study drug orally once daily for 14 weeks. The initial dose of vortioxetine starts at 10 mg per day and may be increased to 20 mg per day based on the study plan. Some participants will receive vortioxetine while others will receive a placebo, and the trial is randomized and double-blind to fairly compare outcomes. During the approximately 20-week study, participants will first spend up to 2 weeks screening for eligibility, then take vortioxetine or placebo for 14 weeks, followed by a 4-week period to monitor any side effects after treatment ends. Participants will visit their clinic 13 times for assessments, which include rating scales for depression symptoms and other health evaluations. Researchers will monitor changes in depression severity using tools like the Children Depression Rating Scale and assess safety through clinical observations and tests.

Researchers are evaluating the efficacy and safety of KarXT for treating schizophrenia in adolescents aged 13 to 17 years. This phase 3, randomized, double-blind, placebo-controlled study aims to better understand how KarXT impacts symptoms of schizophrenia, a serious mental health condition characterized by psychosis and other challenges. The study is sponsored by Bristol-Myers Squibb and focuses on adolescents experiencing active symptoms and meeting diagnostic criteria. Participants are randomly assigned to receive either KarXT or a matching placebo at specified doses on scheduled days. The study uses a parallel design with two groups one receiving the experimental drug KarXT and the other receiving placebo. Treatment and observation last through the study period, with key assessments taking place up to week 5. Participants will undergo evaluations including symptom severity scales such as the Positive and Negative Syndrome Scale PANSS, Clinical Global Impression scales, and the Childrens Global Assessment Scale CGAS. Researchers monitor changes from baseline in these measures to understand the impact of KarXT. Safety and symptom assessments occur throughout the trial, which runs until December 2029, allowing for careful monitoring of participant health and treatment effects.

Researchers are evaluating the efficacy and safety of KarXT in adult Japanese participants who are acutely psychotic with schizophrenia. This Phase 3 study focuses on adults aged 18 to 65 years who meet specific criteria based on psychiatric evaluations and symptom severity scores. The trial aims to understand how KarXT affects schizophrenia symptoms compared to a placebo over a 5-week period, followed by a longer open-label extension. Participants are randomly assigned to receive either KarXT or a placebo during a 5-week double-blind treatment phase. Following this, they may enter a 52-week open-label extension where all participants receive KarXT. The study includes regular dosing on specified days, with careful monitoring throughout both phases. During their participation, individuals undergo assessments of symptom changes using scales like the Positive and Negative Syndrome Scale PANSS and Clinical Global Impressions-Severity CGI-S. Safety is closely monitored through reports of adverse events, physical exams, laboratory tests, heart rate and blood pressure measurements, and other evaluations. The total study duration can last over a year, allowing for detailed observation of treatment effects and safety over time.

Researchers are studying the long-term safety and tolerability of KarXT and KarX-EC in adolescents with schizophrenia and children and adolescents with autism-related irritability. This Phase 3, open-label study evaluates these treatments to better understand their effects over extended periods in these young populations. The trial is led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Participants receive KarXT as the study drug, with dosing specified on certain days. The study includes two groups adolescents aged 13 to 17 years with schizophrenia receiving KarXT alone, and children and adolescents aged 5 to 17 years with irritability associated with autism spectrum disorder receiving KarXT combined with KarX-EC. The treatment period extends up to 54 weeks, during which safety and tolerability are closely monitored. During the study, participants are regularly evaluated for treatment-emergent adverse events, serious adverse events, and adverse events of special interest. Additional assessments include monitoring for procholinergic and anticholinergic symptoms, suicidal ideation and behavior, and movement disorders using validated rating scales. The total participation duration spans up to 54 weeks, encompassing treatment and observation to track long-term effects and safety outcomes.

Researchers are evaluating the effectiveness and safety of the drug SEP-363856 in adults experiencing acute psychotic episodes related to schizophrenia. This Phase 3 clinical trial uses a randomized, double-blind, placebo-controlled design to compare SEP-363856 against placebo in a parallel-group multicenter setting. The study focuses on participants aged 18 to 65 who are experiencing a recent worsening of schizophrenia symptoms. Participants are assigned to one of three groups receiving either a placebo, 75 mgday of SEP-363856, or 100 mgday of SEP-363856 tablets. The study treatment is given daily, and the trial lasts for six weeks. During this time, efficacy and safety data are collected to assess the impact of SEP-363856 on schizophrenia symptoms. Throughout the study, participants undergo regular assessments including the Positive and Negative Syndrome Scale PANSS and the Clinical Global Impression-Severity CGI-S scale to measure symptom changes from baseline to week 6. Safety is monitored as part of the trial. Participants are followed until the end of the six-week treatment period, with all study visits and procedures conducted during this timeframe.

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.