Crystal River

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of AGN-193408 SR in people with open-angle glaucoma or ocular hypertension. This Phase 1/2 study includes different study designs such as an initial open-label dose escalation and later randomized, masked, parallel groups to compare treatments. The study focuses on participants with these eye conditions and aims to measure changes in intraocular pressure and monitor any treatment-related side effects over 36 months. The study uses an implant called AGN-193408 SR, which contains a preservative-free drug dispersed in a biodegradable polymer. The implant is inserted into the front chamber of the study eye using a preloaded applicator. Comparator treatments include topical eye drops of Lumigan 0.01% in the fellow eye and sham administrations using a needleless applicator that simulates the implant procedure. Vehicle eye drops are used for masking in certain cohorts. Treatment schedules vary by cohort, with daily evening eye drops starting from Day 1 in some groups. Participants will be involved in regular assessments to track intraocular pressure changes and any adverse events from baseline up to 36 months. Evaluations include eye exams, monitoring for side effects, and adherence to treatment protocols. Researchers will measure the main outcomes by comparing intraocular pressure at hour 0 from baseline to 36 months and counting participants who experience treatment emergent adverse events during this time frame. The study includes safety follow-up and long-term monitoring throughout the 3-year period.

Researchers are conducting an international, multicenter, observational, non-interventional, prospective, blinded, single-arm study to evaluate the performance of the Cordio HearO system in patients with symptomatic chronic heart failure. The study aims to collect and analyze patient utterances to determine the sensitivity and usable positive negative rate (UPNR) of the HearO system. Participants include adults aged 22 and older diagnosed with symptomatic chronic heart failure classified as NYHA II-IVa who meet specific clinical criteria. The study consists of two periods: a Run-In period during which patients submit daily voice recordings to establish a baseline, followed by a Core period where patients continue daily recordings for up to 24 months or until the end of the study. The HearO app is used solely for data collection without any intervention or treatment changes. The study is designed for continuous remote monitoring through the app. Participants will be involved in daily submission of voice recordings throughout the study duration. Researchers will assess heart failure events, defined as first usable and adjudicated heart failure events, with a total of at least 78 events or a maximum of 24 months per patient marking the end of the study. Safety and clinical stability will be monitored by investigators, and patient consent is required before participation.

Neurotrophic keratopathy (NK) is a degenerative eye disease caused by nerve damage that reduces corneal sensitivity and harms the health of corneal cells. This trial aims to compare the safety and effectiveness of a new eye drop called RGN-259 against a placebo in treating NK. This Phase 3 study focuses on patients with persistent corneal defects and reduced corneal sensation. Participants will receive either RGN-259, a preservative-free eye drop containing Tß4, or a placebo eye drop without Tß4. Both treatments are applied directly to the affected eye(s) five times daily for 28 days. The study monitors healing progress during this treatment period. Throughout the study, participants will undergo evaluations including eye exams to assess corneal healing, sensitivity testing, and vision measurement. The main result measured is the percentage of patients whose persistent corneal defects fully heal by Day 29. Safety and tolerance of the eye drops will also be closely observed during the treatment and follow-up visits.

Researchers are investigating a new atrioventricular interval modulation (AVIM) algorithm within a dual-chamber Medtronic Astra/Azure pacemaker to see how it affects blood pressure control in people with hypertension. This multinational, prospective, randomized, double-blind clinical trial aims to evaluate the safety and effectiveness of the AVIM therapy, which is added to standard antihypertensive drug treatment. The study includes adults who either need or already have an Astra/Azure pacemaker implanted and have high blood pressure. The study has three phases: a screening phase, a double-blind randomized phase lasting one year, and an unblinded phase lasting two years. Eligible participants will have the AVIM algorithm downloaded into their pacemaker and be randomly assigned to either have the AVIM therapy turned ON or OFF. All participants will continue their prescribed blood pressure medications throughout the study. The study compares the effects of activated versus deactivated AVIM therapy on blood pressure. Throughout the study, participants will undergo various assessments including blood pressure monitoring to measure changes in average 24-hour ambulatory systolic blood pressure from baseline at three months. Safety is closely monitored by tracking any serious adverse effects related to the device. The total participation includes long-term follow-up over three years to evaluate both efficacy and safety of the AVIM therapy in managing hypertension alongside standard treatments.

Researchers are evaluating the effects of baxdrostat combined 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 systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.