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Found 8 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.
Actively Recruiting
Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.
Actively Recruiting
Central sleep apnea CSA involves periods during sleep when breathing temporarily stops or decreases due to a lack of effort to breathe. This condition can cause excessive daytime sleepiness and poor sleep quality and is linked to higher mortality in patients with heart failure. Researchers are studying the factors that influence treatment choices and how well patients follow these treatments for CSA in Belgium, as well as the effects of these treatments. Participants in this study will receive routine care as part of a registry, without additional interventions from the study. Eligible participants have a confirmed diagnosis of CSA based on specific breathing event measurements from sleep studies. This observational study will follow patients over five years to monitor their treatment decisions, compliance with treatments, and health outcomes. Throughout the study, participants treatment choices and compliance will be tracked along with assessments of their health-related quality of life and sleep quality using surveys like the Short Form 36 Health Survey and Pittsburgh Sleep Quality Index. Researchers will also monitor mortality over the five-year period. The study involves regular evaluations but no experimental treatments, focusing on real-world data collection to better understand CSA management.
Actively Recruiting
Researchers are evaluating the use of ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy as the first treatment for people with metastatic non-small cell lung cancer NSCLC. This Phase 3, randomized, double-blind, multiregional study involves around 1600 patients divided into two groups based on NSCLC histology squamous and non-squamous. The main goals are to assess overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab or pembrolizumab along with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. The two histology groups will be analyzed separately to understand how each treatment works within these subtypes of NSCLC. This design helps compare the effects of the two treatment combinations. During the study, participants will be monitored for survival and disease progression over several years. Safety assessments include tracking side effects from the start of treatment through 30 to 90 days after the last dose or start of other cancer therapies, with follow-up lasting up to two years. The study includes regular evaluations to measure tumor response and overall health, ensuring comprehensive monitoring throughout the participation period.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the Suicidal Crisis Intervention SCI as a new short-term treatment method for people after a suicidal crisis or suicide attempt. This study aims to determine if SCI can reduce suicidality and also explore its effect on related factors such as hopelessness, defeat, entrapment, and interpersonal needs. The SCI was developed to provide evidence-based care in Flanders, addressing the limited interventions currently available for this high-risk group. The study compares two groups one receiving the SCI alongside their usual treatment, and the other receiving only their usual treatment. The SCI includes four sessions focusing on providing insight into suicidal crises, involving loved ones, creating a safety plan, and ensuring continuity of care. It emphasizes a structured, person-centered approach and aims to motivate participants toward specialized care. Participants will be followed for approximately 222 days after randomization. Researchers will assess changes in suicidality using the Beck Scale for Suicide Ideation at multiple points, along with secondary measures such as suicidal behavior, hopelessness, defeat, entrapment, isolation, follow-up care readiness, and treatment satisfaction. Assessments are conducted at baseline, 42 days, 132 days, and 222 days to monitor progress and outcomes throughout the study period.
Actively Recruiting
Researchers are investigating whether using a catheter-based endovascular device called the WATCHMAN to close off the left atrial appendage can help prevent ischemic stroke or systemic embolism in people with atrial fibrillation who remain at high risk of stroke despite ongoing treatment with oral blood thinners. This study is a multicenter, randomized controlled trial with an open-label design but with blinded assessment of results to ensure unbiased evaluation. Participants will be randomly assigned to either receive the left atrial appendage occlusion with the WATCHMAN device or continue their standard medical care without the device. Those in the device group will undergo the procedure to close off the left atrial appendage using the WATCHMAN device. Both groups will continue their oral anticoagulant treatment as prescribed. The study will continue until 265 primary events of ischemic stroke or systemic embolism occur, with an average follow-up estimated at about 4 years. Throughout the study, participants will be monitored for occurrences of ischemic stroke, systemic embolism, transient ischemic attacks, cognitive function using the Montreal Cognitive Assessment, cardiovascular and all-cause mortality, and new disabling ischemic strokes. Safety and effectiveness will be assessed during the event-driven study period. Participants will be followed for approximately 4 years on average to gather the necessary outcome data and ensure ongoing monitoring of their health status.
Actively Recruiting
Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.