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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Age: 18Years +All GendersPhase 3
282 locations
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Actively Recruiting

This clinical trial is studying adults who have experienced a small ischemic stroke, also known as lacunar stroke. It aims to determine if a combination of antiplatelet drugs dual antiplatelet therapy works as well as the standard treatment with intravenous tissue plasminogen activator rt-PA. Researchers also want to see if the combination reduces bleeding complications compared to rt-PA. Participants will be randomly assigned to receive either the dual antiplatelet therapy, which includes aspirin 200 mg and clopidogrel 300 mg, or intravenous rt-PA at a low dose of 0.6 mgkg alteplase, which is approved in Japan. The study follows a parallel design and is conducted at multiple centers. Treatment is given during the hyperacute phase within 4.5 hours of stroke onset. During the study, participants will be monitored for neurological status at 3 months after stroke through in-person visits, phone calls, or mail. Researchers will measure outcomes such as excellent recovery at 3 months, infarct growth, early neurological changes, stroke recurrence, and cost effectiveness. The total study period extends through March 2029, with primary outcome assessment at 3 months post-stroke.

Age: 18Years +All GendersPhase 4
29 locations
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Actively Recruiting

Researchers are studying whether pemafibrate can help prevent worsening of intracranial arterial stenosis ICAS in adults who have symptomatic ICAS and high triglyceride levels following an ischemic stroke or transient ischemic attack TIA. This open-label, randomized, parallel-group trial compares participants receiving pemafibrate with those receiving standard care without pemafibrate to evaluate its effects on ICAS progression, triglyceride levels, vascular risk markers, vascular events, functional outcomes, and safety over 12 months. Participants will be randomly assigned to either a group receiving pemafibrate plus standard medical therapy or a group receiving standard therapy alone. Those in the pemafibrate group will take the medication for 12 months, with dose adjustments possible based on triglyceride levels and kidney function. Both groups will continue standard stroke care, including treatments for blood pressure, cholesterol, diabetes, and smoking. Brain CT angiography CTA will be performed at the start of the study and after 12 months. Additional imaging and vascular tests like brain MRIMRA, ankle brachial index, cardio ankle vascular index, and pulse wave velocity will follow the study schedule. Throughout the year-long study, participants will have blood tests and clinical assessments at baseline and during follow-up visits. Researchers will monitor vascular events, functional outcomes using scales such as the modified Rankin Scale, and adverse events. Changes in intracranial arterial stenosis on CTA are the main outcome measured at baseline and 12 months. Safety and multiple vascular and imaging markers will be evaluated at various points. Participants will be followed closely for one year to assess the effects and safety of pemafibrate in this population.

Age: 18Years +All GendersPhase Not Applicable
37 locations