Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
NCT07218783 · Cataract, Glaucoma,
Ocular Hypertension RecruitingThis trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
PhasePhase 3
TypeInterventional
Age22 Years
WhereHouston, Texas, United States
SponsorSpyGlass Pharma, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
NCT05889650 · Severe Traumatic Brain Injury,
Intracranial Hypertension RecruitingThe goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \<5mm without increasing the risk of neurological worsening or cerebral herniation. All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereGainesville, Florida, United States + 5 more
SponsorBrain Trauma Foundation
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma
NCT06822738 · Primary Open Angle Glaucoma
RecruitingGlaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed. XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in the United States. Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
PhasePhase 3
TypeInterventional
Age45 Years
WhereGlendale, Arizona, United States + 26 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
NCT06559891 ·
Hypertension RecruitingThe primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in: 1. subjects with uncontrolled hypertension (HTN) receiving 0 - 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure. 2. subjects with controlled hypertension receiving 1 - 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure
PhaseNA
TypeInterventional
Age22 Years – 75 Years
WhereBirmingham, Alabama, United States + 49 more
SponsorSoniVie Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
NCT06129240 ·
Pulmonary Hypertension, Interstitial Lung Disease
RecruitingStudy LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.
Phase—
TypeObservational
Age18 Years – 80 Years
WherePhoenix, Arizona, United States + 22 more
SponsorLiquidia Technologies, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
RecruitingThis open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereFresno, California, United States + 119 more
SponsorGossamer Bio USA, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
NCT07181109 · High Risk Cardiovascular Disease,
Hypertension, High Cardiovascular Risk
RecruitingThe purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 1104 more
SponsorAlnylam Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
NCT06526195 ·
Heart Failure, Heart Diseases, Cardiovascular Diseases
RecruitingThe purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
PhaseNA
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 67 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts PRESSURE CHECK: Find Your Path to Better Health
NCT06122246 ·
Blood Pressure RecruitingThis study seeks to develop the evidence for a sustainable, community-partnered, multi-level health system strategy to improve blood pressure control. Two team-based approaches are being tested: 1) a medical model of remote BP management (RBPM) alone, and 2) RBPM plus a social model with a community health worker (CHW). These 2 strategies are being compared with a standard community screening program with referral to primary care.
PhaseNA
TypeInterventional
Age18 Years
WhereNew Haven, Connecticut, United States + 3 more
SponsorYale University
▾Tap for detailsClick for full details — eligibility, all locations, contacts LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
RecruitingThe purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
PhasePhase 3
TypeInterventional
Age18 Years – 85 Years
WhereAlexander City, Alabama, United States + 140 more
SponsorTenax Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
RecruitingInternational, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
PhasePhase 3
TypeInterventional
Age18 Years
WhereFairhope, Alabama, United States + 770 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pulmonary Hypertension Association Registry
RecruitingThe PHA Registry (PHAR) is a national study about people who have pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects information from people with PAH and CTEPH who are cared for in participating PHA-accredited Pulmonary Hypertension Care Centers throughout the U.S. PHAR will determine how people with PAH and CTEPH are evaluated, tested, and treated, and will observe how well these participants do. The goal is to see if people with PH are treated according to recommended guidelines, and to see if there are certain factors that can lead to better or worse outcomes. PHAR will include information about people with PAH and CTEPH in the U.S. who are seen at participating PHA-accredited PH Care Centers. PHAR contains data about patient care and outcomes. Specifically, data in the PHAR includes information on diagnosis; clinical status; socioeconomic status; diagnosis test results; body size; treatment information; interest in participating in clinical trials; family health and social history; and information about smoking, alcohol, or drug use. Participants are followed over time, and provide updates such as changes in therapy, how often participants need to go to the hospital, and survival. Such information may help healthcare providers provide better care.
Phase—
TypeObservational
Age0 Years
WherePhoenix, Arizona, United States + 51 more
SponsorPulmonary Hypertension Association, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
RecruitingA prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
PhaseNA
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 130 more
SponsorOrchestra BioMed, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
NCT05401357 · Glaucoma, Open-Angle,
Ocular Hypertension RecruitingThis is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
PhasePhase 3
TypeInterventional
Age18 Years
WhereNewport Beach, California, United States + 8 more
SponsorAmneal Pharmaceuticals, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Comparative, Randomized, Investigator-blind, Active-controlled, Parallel-group, Multicenter, Clinical Endpoint Study
NCT07661329 · Primary Open Angle Glaucoma (POAG),
Ocular Hypertension (OH) RecruitingThis study is to establish non-inferiority of a preservative free formulation of Bimatoprost ophthalmic solution 0.01% (YSBP) of YS Life Science Co., Ltd. compared to LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of AbbVie INC in subjects with primary open angle glaucoma (POAG) or ocular hypertension.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBeverly Hills, California, United States + 15 more
SponsorYS Life Science Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
NCT07610278 · Hypercholesterolaemia
RecruitingThis is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereFoley, Alabama, United States + 28 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
NCT07333183 ·
Pulmonary Hypertension, Interstitial Lung Disease (ILD), Lung Diseases
RecruitingThis is a Phase 2, open-label, multi-center clinical study to evaluate the safety and tolerability of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.
PhasePhase 2
TypeInterventional
Age18 Years – 85 Years
WhereSanta Barbara, California, United States + 12 more
SponsorPulmovant, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
NCT05213676 · Congenital Diaphragmatic Hernia
RecruitingThe purpose of this study is to determine if de-implementation of inhaled nitric oxide (iNO) in the post-natal resuscitation/stabilization phase affects the composite outcome of extracorporeal life support (ECLS) use and/or mortality, as well as ECLS use, mortality, and/or oxygenation in congenital diaphragmatic hernia (CDH) newborns and to establish the cost-effectiveness of de-implementing iNO as a therapy in the postnatal resuscitation/stabilization phase of CDH management, which will be assessed as the incremental health system costs (savings) per prevented ECLS use and/or death.
PhasePhase 4
TypeInterventional
Age0 Months – 1 Month
WhereBirmingham, Alabama, United States + 18 more
SponsorThe University of Texas Health Science Center, Houston
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
NCT06843577 · Elevated Blood Pressure,
Hypertension RecruitingThe study will be a multi-center, randomized clinical trial to evaluate the safety and efficacy of using the Zona Plus handgrip therapy device compared to the use of an auditory relaxation therapy for treatment of high blood pressure and hypertension in subjects who are not currently taking antihypertensive medications. Half of the study subjects will also be randomized to record blood pressure at home throughout the study.
PhaseNA
TypeInterventional
Age22 Years
WhereValley Village, California, United States + 9 more
SponsorZona Health, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
RecruitingThis study evaluates the effect of ROC-101 in adults with either Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH). Each eligible participant will receive standard of care (SOC) plus ROC-101 for a 24-week treatment period, followed by a long-term extension period of the study through the end of the program or marketing approval/authorization.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WherePhoenix, Arizona, United States + 22 more
SponsorAllRock Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts