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Found 11 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate the effects of a multi-component intervention designed to reduce alcohol use and related harms such as motor vehicle crashes, fatalities, heavy or binge drinking, underage drinking, and drinking and driving. The study compares six intervention cities implementing these strategies with six matched cities that do not receive such interventions, with plans to expand to nine intervention and nine comparison cities. The intervention includes screening and brief interventions by health providers, enforcement of laws like drink-driving and underage drinking restrictions, and novel or partially tested approaches needing further evaluation. The intervention group cities receive a combination of strategies including screening and brief intervention by health providers, enforcement of existing alcohol policies, and new or partially tested interventions aimed at reducing harmful alcohol use. The comparison cities do not receive these evidence-based interventions. The study collects data over multiple years from both adults and youth through surveys and archival records to assess the impact of these interventions on alcohol-related harms and behaviors. Participants contribute through cross-sectional surveys conducted before and after the intervention to assess alcohol use behaviors, perceptions, and policy awareness. Researchers also collect archival data on incidents such as motor vehicle crashes, fatalities, violence, and injuries related to alcohol use. Key outcomes measured include health and social harms related to alcohol use over one year, heavybinge drinking, underage drinking, and attitudes towards alcohol policies. The study involves multiple years of follow-up and multi-level analyses to evaluate whether the intervention achieves at least a 10% reduction in harmful alcohol use.
Actively Recruiting
Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.
Actively Recruiting
Researchers are evaluating olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.
Actively Recruiting
This research aims to evaluate the long-term safety and tolerability of pelacarsen TQJ230 administered once a month at 80 mg in patients who have elevated lipoproteina and established atherosclerotic cardiovascular disease ASCVD. The study is an open-label, rollover extension designed for participants who have successfully completed prior double-blind parent studies involving pelacarsen. Participants will receive open-label pelacarsen 80 mg by subcutaneous injection once every month during this extension program. This phase 3 study continues treatment from the parent trial and provides post-trial access to pelacarsen for eligible participants who completed their assigned treatments previously. During the study, participants will be monitored for adverse events and serious adverse events for up to 48 months. Researchers will also assess changes in lipoproteina levels compared to baselines from both the parent and extension studies at multiple time points, including baseline, 3, 12, 24, 36, and 48 months. Participants are expected to attend scheduled visits for safety evaluations and lab tests throughout the study duration.
Actively Recruiting
This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.
Actively Recruiting
Researchers are evaluating the safety, tolerability, and effectiveness of acalabrutinib combined with rituximab in elderly andor frail patients with diffuse large B-cell lymphoma DLBCL who have not received prior treatment and are unsuitable for standard chemotherapy. This Phase II study focuses on patients aged 65 and older, aiming to find treatment options for those who cannot undergo usual frontline chemoimmunotherapy. Participants will receive oral acalabrutinib starting on Cycle 1 Day 1 for up to 28 cycles or until disease progression or other reasons for stopping. Additionally, rituximab will be given intravenously on Cycle 1 Day 15, followed by subcutaneous injections from Cycle 2 Day 1 through Cycle 8. The study involves a single treatment arm with this combination therapy. Each participant will be involved for up to 108 weeks, including up to 28 days for screening and 104 weeks for treatment and follow-up. Researchers will assess adverse events, objective response rate, progression-free survival, overall survival, and functional mobility using the Timed Up and Go test. Safety monitoring continues throughout the study, including up to 30 days after treatment ends, to evaluate treatment-emergent adverse events and long-term outcomes.
Actively Recruiting
Researchers are evaluating the combination of NXP900 and osimertinib in adults with advanced, progressing non-small cell lung cancer NSCLC that has mutations in the EGFR gene. This Phase 1b, open-label study aims to explore the safety and treatment effects of this combination in patients who have already been treated with osimertinib. Participants receive escalating doses of NXP900, a drug taken by mouth that inhibits SRC family kinases, together with osimertinib, an oral EGFR inhibitor. This combination is given during the dose exploration phase to find appropriate levels and monitor effects. The study is conducted at multiple centers and involves sequential treatment steps. During the study, participants will be monitored for treatment-related side effects and laboratory changes for up to 30 days after treatment. Researchers will also measure how well the cancer responds to treatment over about 12 months, including the response rate, duration of response, and disease control rate. The study lasts until the completion date in June 2027, with ongoing assessments throughout the treatment period.
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