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Hyperlipoproteinemias clinical trials

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NCT ID: NCT04640012 Completed - Hyperlipidemia Clinical Trials

Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects

Start date: September 25, 2020
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety, tolerability, pharmacokinetics of DC371739 after a single-dose oral administration in healthy Chinese subjects, and to explore the maximum tolerated dose, also the pharmacokinetics of urine and feces.

NCT ID: NCT04608474 Recruiting - Hyperlipidemias Clinical Trials

Lipid Management in Renal Transplant Recipients Using Evolocumab.

Start date: February 17, 2021
Phase: Phase 4
Study type: Interventional

Cardiovascular disease is the leading cause of mortality after renal transplantation, accounting for more than 30% of deaths. Elevated lipid levels (hyperlipidemia) are a frequent finding following transplantation and the immunosuppressive medications play a central role in the development or worsening of hyperlipidemia. In the general population, the correlation between elevated serum cholesterol and increased risk of cardiovascular disease is well established and the reduction in serum LDL cholesterol has proved to significantly reduce both morbidity and mortality. Statin based drugs are the standard of care in the management of hyperlipidemia. Commonly used statin-based drugs include atorvastatin (Lipitor), fluvastatin (Lescol, Lescol XL), lovastatin (Mevacor, Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), and pitavastatin (Livalo). These drugs have been proven to lower lipid levels as well as cardiovascular risk. However, statin-based drugs also cause a variety of side effects. While the most commonly encountered side effects are toxicity to the liver and muscles, a few others have also been known to cause increased excretion of protein in the urine and kidney failure. These side effects are also more common in a renal transplant recipient due to the simultaneous administration of drugs that prevent rejection. Therefore, there is an emergent need for newer drugs which are both efficient and safe especially in this population PCSK-9 inhibitors (Proprotein Convertase Subtilisin Kinase-9 inhibitors) are a new class of drugs that are highly efficient in lowering lipid levels in the general population. However, an exclusive trial involving kidney transplant recipients is yet to be done. Through this study, we would like to evaluate the safety and tolerability of Evolocumab (trade name: Repatha) which is a PCSK-9 inhibitor developed by Amgen, Inc in renal transplant recipients. The study would involve a total of 120 patients across 3 different hospitals in Boston, Massachusetts.

NCT ID: NCT04606602 Completed - Dyslipidemias Clinical Trials

Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)

Start date: November 18, 2020
Phase: Phase 1
Study type: Interventional

This study will investigate the safety and tolerability of SLN360 in patients with elevated Lp(a).

NCT ID: NCT04573218 Completed - Clinical trials for Hypercholesterolemia

Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia

Start date: October 18, 2021
Phase: Phase 2
Study type: Interventional

An unpublished study by the investigators on healthy participants has shown that the supplementation of oil palm phenolics (OPP) at 250 mg is the optimum dose to demonstrate the ability to lower total and LDL cholesterol. There is no clinical evidence as yet on that optimum dosage of OPP supplementation in improving fasting lipid profile in minor hyperlipidemia subjects. The investigators hypothesize that in a clinical study, OPP supplemented to the minor hyperlipidemic participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability. OPP may have the potential to be positioned as natural health supplement in improving lipid profile.

NCT ID: NCT04516291 Completed - Dyslipidemias Clinical Trials

A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)

Start date: September 28, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy, safety, tolerability, and pharmacokinetics (PK) of PF-07285557 (hereafter, vupanorsen) administered subcutaneously (SC) at various doses and regimens in participants with dyslipidemia, defined in this study as participants with elevated non-HDL-C and TG who are receiving a stable dose of a statin. This study is also known as TaRgeting ANGPTL3 with an aNtiSense oLigonucleotide in AdulTs with dyslipidEmia (TRANSLATE-TIMI 70).

NCT ID: NCT04488497 Recruiting - Clinical trials for Cardiovascular Diseases

Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:

CARE RA
Start date: January 27, 2021
Phase: N/A
Study type: Interventional

One of the greatest success stories in rheumatology - the achievement of rheumatoid arthritis (RA) remission - is tempered by the fact that individuals with RA are dramatically under evaluated and under treated to reduce the risk for heart attacks and strokes. This project will build the foundation for an intervention that will test the hypothesis that the patient-centered intervention tailored to patients with RA to improve hyperlipidemia screening and treatment, thereby decreasing the risk for heart attacks and strokes. The aims of this proposal are: Aim 1: To identify patient and physician barriers to lower the risk for heart attacks and strokes in patients with RA. Aim 2: To develop an intervention designed to optimize lipid screening and management in RA patients. This will consist of patient education and a decision support program to facilitate screening for hyperlipidemia (high cholesterol level) or initiation of medications to lower cholesterol (primary outcome) and self-efficacy (level of confidence in performing a task) in taking medications to lower cholesterol secondary outcome). Aim 3: To pilot test the efficacy and feasibility of intervention developed in Aim 2. The investigators will apply methods related to clinical trials to test the feasibility of the newly developed intervention.

NCT ID: NCT04469673 Completed - Hyperlipemia Clinical Trials

A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..

Start date: May 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

NCT ID: NCT04433533 Recruiting - Hyperlipidemias Clinical Trials

Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia

Start date: January 6, 2021
Phase: Phase 4
Study type: Interventional

preserved left ventricular ejection fraction (LVEF ≥ 50%) and are accompanied by dyslipidemia (LDL ≥ 100 mg / dl) will be enrolled. Only patients who do not meet the exclusion criteria should be enrolled in the study. Once the patient is selected, the patient is informed of the study and receives the consent form. Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly assigned in a 1: 1 dose of rosuvastatin/ezetimibe 10/10mg once daily or rosuvastatin 20 mg once daily. Patients who previously used statins have a wash-out period of 4 weeks or more. Patients will visit outpatient clinic at 12 weeks and 24 weeks after initiation of treatment. Physical examination, blood test, and 6 minute working test will be performed. For fasting blood tests, patients visit on an empty stomach. Drug adverse events and changes in vital signs or body weight will be checked. After 48 weeks of treatment, the patients will visit outpatient clinic for efficacy evaluation; physical examination, blood test, transthoracic echocardiography, cardiopulmonary exercise test, central blood pressure, and pulse wave velocity. Drug adverse events and medication compliance will be checked. The primary endpoint is change of low-density lipoprotein cholesterol and secondary endpoint is improvement of diastolic dysfunction, VAC index, peak VO2, distance of 6 minute working test, and clinical outcomes including death, readmission rate.

NCT ID: NCT04394715 Completed - Clinical trials for High Risk Atherosclerotic Cardiovascular Disease

Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This study is designed to evaluate the efficacy of automated electronic alerts in the electronic health record to improve rates of best practices in the treatment of patients with hyperlipidemia who present in the setting of outpatient primary care and family medicine practices within the Yale New Haven Health System.

NCT ID: NCT04330209 Completed - Weight Loss Clinical Trials

Comparing a Low-GI Nutrigenetic and Ketogenic Diet for Weight Loss With 18 Month Follow-up

LOWGI_GENE
Start date: January 1, 2014
Phase:
Study type: Observational

The investigators followed a convenience sample of 114 overweight and obese subjects from a weight loss clinic who followed a 24-week dietary intervention. The subjects self-selected whether to follow a standardized ketogenic diet (n=53), or a personalised low-glycemic index (GI) diet utilising information from 28 single nucleotide polymorphisms (n=61). After the 24-week study period, the subjects were monitored for an additional 18 months.