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Found 10 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety, effectiveness, and how the body processes and responds to NXT007 prophylaxis compared with emicizumab prophylaxis in people aged 12 years and older who have severe or moderate congenital hemophilia A without factor VIII FVIII inhibitors, or any severity of hemophilia A with FVIII inhibitors. This phase 3, randomized, open-label study aims to compare these treatments to better understand their impact on bleeding rates and treatment burden. Participants will be randomly assigned to one of two main treatment groups. One group will receive NXT007 prophylaxis administered subcutaneously using an integrated drug-device combination product. The other group will receive emicizumab prophylaxis via subcutaneous injections, starting with weekly loading doses for 4 weeks, then maintenance dosing at various intervals depending on prior treatment status. After the main treatment period, participants from both arms can continue or switch to NXT007 in an open-label extension phase. Throughout the study, participants will be closely monitored with regular assessments, including measuring annualized bleed rates for different types of bleeds, treatment burden questionnaires, and safety evaluations such as adverse event monitoring and laboratory tests. These evaluations will continue throughout approximately 3.5 years of study participation to provide comprehensive data on treatment effects and safety.

Age: 12Years +All GendersPhase 3
30 locations
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Actively Recruiting

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Age: 50Years +All GendersPhase 3
567 locations
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Actively Recruiting

This research aims to evaluate the antiviral effects of S-337395 compared with a placebo in adults who are not hospitalized but have respiratory syncytial virus RSV infection and are at high risk of progressing to severe disease. Participants must start treatment within 72 hours of showing RSV symptoms. The study is a Phase 2b trial and involves adults with specific risk factors such as older age and chronic lung or cardiovascular disease. Participants will be randomly assigned to receive either a high dose or low dose of S-337395, or a matching placebo. The treatment is given orally twice daily for up to 5 days. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered during the trial. Throughout the study, participants will be monitored closely with assessments including nasal swabs to measure RSV RNA levels at several time points up to day 6. Researchers will also track symptoms using questionnaires and record any side effects up to 28 days. Blood samples will be collected to measure drug levels, and safety will be monitored throughout the study, which runs until December 2026.

Age: 18Years +All GendersPhase 2
84 locations
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Actively Recruiting

This research aims to evaluate the effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

Age: 18Years - 63YearsAll GendersPhase 3
128 locations
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Actively Recruiting

Researchers are evaluating how well vortioxetine, given at doses of 10 mg or 20 mg per day, works compared to a placebo to treat depression symptoms in Japanese teenagers aged 12 to 17 years diagnosed with Major Depressive Disorder MDD. The study focuses on assessing both the effectiveness and side effects of vortioxetine in this young population. Participants will take the study drug orally once daily for 14 weeks. The initial dose of vortioxetine starts at 10 mg per day and may be increased to 20 mg per day based on the study plan. Some participants will receive vortioxetine while others will receive a placebo, and the trial is randomized and double-blind to fairly compare outcomes. During the approximately 20-week study, participants will first spend up to 2 weeks screening for eligibility, then take vortioxetine or placebo for 14 weeks, followed by a 4-week period to monitor any side effects after treatment ends. Participants will visit their clinic 13 times for assessments, which include rating scales for depression symptoms and other health evaluations. Researchers will monitor changes in depression severity using tools like the Children Depression Rating Scale and assess safety through clinical observations and tests.

Age: 12Years - 17YearsAll GendersPhase 3
30 locations
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Actively Recruiting

This research aims to learn about the safety and effects of the study medicine PF-07328948 for adults with heart failure. The study evaluates whether PF-07328948 is safe and effective compared to a placebo in people who already take standard heart failure medicines including SGLT2 inhibitors. It is a phase 2 randomized, double-blind, placebo-controlled trial sponsored by Pfizer. Participants will take either placebo tablets or one of three doses of PF-07328948 tablets once daily by mouth for 36 weeks. The study includes four groups placebo, low dose, medium dose, and high dose of PF-07328948. Treatment lasts 36 weeks, followed by monitoring and assessments. Participants will be involved for about 48 weeks with 15 visits to the study clinic, of which 5 may be performed at home by phone and 10 in person. Researchers will assess clinical events, 6-minute walk test distance, and heart failure symptom scores at baseline and week 36. Safety will be monitored through adverse event reporting up to week 40. Various questionnaires and physical tests will track health status and treatment effects throughout the study.

Age: 18Years - 79YearsAll GendersPhase 2
142 locations
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Actively Recruiting

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Age: 45Years - 99YearsAll GendersPhase 3
782 locations
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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.

Age: 18Years - 99YearsAll GendersPhase 3
628 locations
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Actively Recruiting

Researchers are evaluating the overall survival of patients with stage I epithelial ovarian cancer after they have undergone comprehensive staging surgery. This phase III trial compares the outcomes of adjuvant chemotherapy versus observation alone. The study aims to determine whether adding chemotherapy after surgery improves survival in this patient group. Participants will be randomly assigned to one of two groups. One group receives adjuvant chemotherapy, which includes either a combination of paclitaxel and carboplatin or docetaxel and carboplatin, given every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. The other group undergoes observation without chemotherapy. During the study, participants will be monitored for overall survival up to 60 months from randomization. Researchers will also assess relapse-free survival within the same timeframe. Evaluations include follow-ups to track disease progression, side effects, and general health. The study ensures participants receive appropriate care and measures outcomes to better understand treatment benefits and risks.

Age: 20Years +FEMALEPhase 3
103 locations
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Actively Recruiting

This research aims to evaluate the safety and effectiveness of long-term use of fostamatinib in Japanese patients with chronic idiopathic thrombocytopenic purpura ITP. It focuses on understanding how the drug performs under real-world conditions in this patient population. The study is observational, meaning it monitors patients without altering their treatment plans. Participants receive fostamatinib through oral administration as part of their regular care. The study does not assign treatment but observes patients already starting fostamatinib for the first time. There are no separate treatment or placebo groups since this is not an interventional trial. During the study, researchers will collect data on any adverse events over an 18-month period to assess the drugs safety. Participants health and response to the medication will be monitored through routine clinical visits. The total duration of participation aligns with the long-term observation of treatment effects and side effects.

All Genders
1 location