91 Clinical Trials for Various Conditions
Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations.
Diabetes, Hypertension, High Cholesterol/Hyperlipidemia, Coronary Artery Disease, Congestive Heart Failure, Chronic Lung Disease, Chronic Kidney Diseases, Arrythmia, Stroke, Depression, Anxiety, Pulmonary Embolism, Heart Attack
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by lowering low density lipoprotein levels, they may also have pleiotropic effects on inflammation. The immunomodulatory effects of these medications are relevant to ASCVD risk reduction given that inflammation plays a central role in atherosclerotic plaque formation (atherogenesis) and influences the development of vulnerable plaque morphology. Patients on statins, however, may have residual inflammation contributing to incident ASCVD despite the potent LDL-lowering effects of statins. While new therapies, such as proprotein convertase subtilisin/kexin type 9 (PSCK9) inhibitors, further reduce incident ASCVD and drastically reduce LDL-C below that achieved by statin therapy alone, PCSK9 inhibitors may also have pleiotropic effects on inflammation. Thus, PCSK9 inhibitors may help reduce arterial inflammation to a level closer to that of patients without ASCVD. This study will apply a novel targeted molecular imaging approach, technetium 99m (99mTc)-tilmanocept SPECT/CT, to determine if residual macrophage-specific arterial inflammation is present with statin therapy and the immunomodulatory effects of PSCK9 inhibition. Given the continued high mortality and morbidity attributable to ASCVD, strong imperatives exist to better understand the immunomodulatory effects of lipid lowering therapies and residual inflammatory risk. This understanding, in turn, will inform the development of new ASCVD preventative and treatment strategies as well as elucidate other indications for established therapies.
Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases, Atherosclerosis, Arterial Inflammation, Vascular Diseases, Vascular Disease, Peripheral, Vascular Calcification, High Cholesterol/Hyperlipidemia, Heart Diseases, Heart Attack, Stroke, Cerebrovascular Accident, Carotid Artery Diseases, Carotid Atherosclerosis, Transient Ischemic Attack
The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.
Healthy
Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood. This study will enroll normal-weight adults, will identify "responders" who develop high cholesterol on a ketogenic diet, and will measure rates of production and removal of certain types of cholesterol-carrying particles called lipoproteins in responders. The results will clarify the mechanism by which a ketogenic diet can cause high cholesterol in certain susceptible people.
Hypercholesterolemia and Hyperlipidemia
The primary goal is to assess the impact of Evolocumab therapy on platelet function of familial hypercholesterolemia (FH) patients in a randomized, double blind study. Evolocumab is a humanized monoclonal antibody that targets circulating PCSK9, increases hepatic LDL receptor, decreases plasma LDL cholesterol and reduces risk of cardiovascular events. Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol. The secondary goal is to determine if platelet activation or the response to Evolocumab therapy is modified by rs3184504 polymorphism. The investigators believe that these investigations will complement ongoing studies to demonstrate that Evolocumab reduces athero-thrombotic risk and aid the decision-making as to whether Evolocumab can reduce the atherothrombotic risk in acute coronary syndrome (ACS) patients.
Familial Hypercholesterolemia
The purpose of this randomized clinical trial is to learn if 'complex' cancer patients who receive care guided by a health system intervention, Primary Care Connect (PC2) have their risks of cardiovascular disease (CVD) managed better than those who receive usual care. This study focuses on "complex" cancer survivors who have higher CVD risk when diagnosed with cancer because they also have had a diagnosis of 1 or more chronic conditions (e.g., hypertension, diabetes, and/or hyperlipidemia) requiring medication management. This study also aims to learn about the ease of implementing the health system intervention from the perspectives of cancer teams, primary care teams, and complex cancer patients. The main questions the study aims to answer are: * Do patients enrolled in the PC2 arm remain connected to their primary care teams during active cancer treatment for chronic disease management compared to patients in usual care? * Do patients enrolled in the PC2 arm have better management of their chronic conditions during active cancer treatment compared to patients in usual care? * How do the care team and patients experience this change in care delivery related to their work and care experiences? This study will compare complex cancer survivors who receive care according to the PC2 intervention to usual care to see if PC2 works to improve cardiovascular risk management. Participants will: * receive educational materials about the study upon enrollment * complete on-line or written surveys at 4 times * Visit the clinic for check ups and test related to the study 4 times
Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Bladder Cancer, Prostate Cancer (Adenocarcinoma), Endometrial Cancer, Hypertension, Hyperlipidemia (E.G., Hypercholesterolemia), Diabetes Mellitus
The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol not adequately controlled by their current therapy.
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases
The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.
Hyperlipidemia
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
Hyperlipidemia and Mixed Dyslipidemia
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).
Hyperlipidemia
The purpose of this study is to determine the role of time of dosing on the lipid-lowering effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with hypercholesterolemia.
Hypercholesterolemia
The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.
Hypercholesterolemia, Hyperlipidemia, Familial Combined
A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in combination with Atorvastatin Total participation for each patient is approximately 16-17 weeks, which may include up to a 2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up. During the run-in period patients taking statins, statin combination or Zetia will undergo a 'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their same diet prior to entering the study). They will be asked to defer initiating any weight loss diets or meaningful changes in their activity level until after they have completed the study. Once randomized into the double blind study, patients will visit the clinic every two weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the double-blind study medication will be discontinued. Patients will attend a follow up visit two weeks after their final dose for safety evaluation.
Hyperlipidemia
This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle pain. The study will determine whether red yeast is associated with a lower level of muscle related complaints compared to pravastatin.
Hypercholesterolemia, Statin-Associated Myopathy
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.
Hyperlipidemia, Dyslipidemia, Hypercholesterolemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.
Hyperlipidemia, Dyslipidemia, Hypercholesterolemia
The purpose of this study is to see if combination therapy with a "statin" medication and two additional agents that work differently than "statin" medications can further lower the so-called "bad cholesterol." One therapy is a prescription drug approved by the Food and Drug Administration to treat high cholesterol (Welchol). The other therapy is Minute Maid Heart Wise orange juice. This study juice is available in supermarkets and contains plant sterols that have been shown to lower cholesterol.
Hyperlipidemia, Dyslipidemia
The purpose of this study is to determine if patients with elevated cholesterol, but not taking any other lipid medication, could lower their cholesterol with administration of lapaquistat acetate, once daily (QD).
Dyslipidemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.
Hyperlipidemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).
Familial Hypercholesterolemia - Heterozygous
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to \<12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDLC).
Familial Hypercholesterolemia - Homozygous
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
The primary objectives of this study are to evaluate the safety of MD-0727 in patients with primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C) lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia.
Hypercholesterolemia
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), to lower cholesterol in subjects with homozygous familial hypercholesterolemia undergoing lipid-lowering treatment.
Hypercholesterolemia
The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or with additional statin therapy on cholesterol levels in treating patients with elevated cholesterol.
Hypercholesterolemia
Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.
Dyslipidemia
The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily (QD), on lowering cholesterol in subjects already taking atorvastatin.
Hypercholesterolemia
This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (PK) measurements.
Hyperlipidemia, NAFLD
The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia