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Found 8 Actively Recruiting clinical trials

A

Actively Recruiting

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Age: 18Years +All GendersPhase 3
759 locations
A

Actively Recruiting

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Age: 18Years +All Genders
163 locations
A

Actively Recruiting

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Age: 18Years +All GendersPhase 3
422 locations
B

Actively Recruiting

Central sleep apnea (CSA) is a condition where breathing stops or decreases during sleep due to reduced respiratory effort. This research aims to study the factors that influence treatment decisions and how well patients follow their treatment plans for CSA in Belgium. The study also seeks to better understand the clinical features and effects of CSA, especially given its link to daytime sleepiness and risks in heart failure patients. Participants will receive routine care as part of a registry; there is no experimental treatment involved. The study collects information on the treatments chosen for CSA and monitors patient compliance and outcomes over time. During the study, researchers will gather data through standard clinical assessments and sleep studies to evaluate treatment choices and patient adherence. The primary outcome is the treatment choice over a five-year period. Participants will be followed to observe how treatments affect their condition and overall health.

Age: 18Years +All Genders
14 locations
C

Actively Recruiting

Researchers are conducting a Phase 3, randomized, double-blind, multiregional study to compare two treatments for metastatic non-small cell lung cancer (NSCLC). The study includes two separate groups based on NSCLC histology: squamous and non-squamous types. The main goals are to evaluate overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab combined with platinum-doublet chemotherapy or pembrolizumab combined with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. Each histology group will be analyzed separately, with about 600 patients in the squamous group and 1000 in the non-squamous group. During the study, participants will be monitored for survival outcomes over approximately 3 to 4 years. Researchers will assess tumor response and safety through regular evaluations. Eligibility requires confirmed metastatic NSCLC, with specific tumor measurements and no prior systemic treatment for metastatic disease. This study aims to provide important information on these first-line treatment options for metastatic NSCLC.

Age: 18Years +All GendersPhase 3
253 locations
E

Actively Recruiting

Healthy Volunteer

This research investigates the Suicidal Crisis Intervention (SCI), a new short-term treatment designed to reduce suicidality in people who have experienced a suicide attempt or suicidal crisis. The study also aims to explore the effect of SCI on related factors such as hopelessness, defeat, entrapment, and interpersonal needs. The SCI was developed in Flanders to address the lack of specific evidence-based short-term treatments for this high-risk group. The SCI consists of four structured sessions that focus on understanding the suicidal crisis by relating it to the person's life history. It seeks to increase motivation for ongoing specialized care and involves the participation of close relatives to strengthen social support. Key elements of the intervention include a safety plan, person-centered care, and continuity of care, all delivered by care providers within a short time frame. Participants will be monitored for changes in suicidality using the Beck Scale for Suicide Ideation at multiple points: 42, 132, and 222 days after randomization. The study includes assessments of related psychological factors and emphasizes the involvement of relatives. Participants must have internet access and be Dutch-speaking. The total duration and detailed follow-up procedures support evaluating both immediate and longer-term effects of the SCI.

Age: 18Years +All GendersPhase Not Applicable
12 locations
T

Actively Recruiting

Researchers are evaluating whether catheter-based endovascular left atrial appendage occlusion can prevent ischemic stroke or systemic embolism in people with atrial fibrillation who remain at high risk of stroke despite ongoing treatment with oral anticoagulants. This multicenter, prospective, open-label randomized trial uses blinded assessment of outcomes to provide clear results. The study focuses on participants with persistent, permanent, or certain types of paroxysmal atrial fibrillation and elevated stroke risk. Participants will receive treatment using the WATCHMAN device to perform left atrial appendage occlusion through a catheter-based approach. This device-based intervention is compared to usual care with oral anticoagulants, which participants must have been taking for at least 90 days before enrollment. The study period is event-driven and will continue until 265 primary endpoint events of ischemic stroke or systemic embolism occur, with an estimated average follow-up of about 4 years. During the study, participants will be closely monitored for stroke or embolism events as the primary outcomes. The trial assesses the safety and efficacy of the procedure in addition to ongoing anticoagulant therapy. Participants must be able to provide informed consent and are followed throughout the study duration to evaluate these outcomes.

Age: 18Years +All GendersPhase Not Applicable
127 locations
Z

Actively Recruiting

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.

Age: 18Years +All GendersPhase 3
742 locations