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Dyslipidemias clinical trials

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NCT ID: NCT05809687 Not yet recruiting - Dyslipidemias Clinical Trials

Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

NCT ID: NCT05749874 Not yet recruiting - Hypertension Clinical Trials

Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus

ABCD
Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine on preventing cardiovascular disease and diabetes mellitus among individuals with high cardiometabolic risk in China.

NCT ID: NCT05701813 Not yet recruiting - Obesity Clinical Trials

The Study Aims to Investigate the Effects of Oral Inositols on Insulin-resistance in Children With Obesity.

ONIRICO
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The study aims to investigate the effects of oral inositols on insulin-resistance and metabolic variables (triglycerides, total cholesterol, HDL cholesterol) in children aged 8-12 years with obesity and insulin-resistance.

NCT ID: NCT05621070 Not yet recruiting - Clinical trials for Primary Hypercholesterolaemia and Mixed Dyslipidemia

Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

Start date: December 2, 2022
Phase: Phase 3
Study type: Interventional

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia. In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.

NCT ID: NCT05579418 Not yet recruiting - Dyslipidemias Clinical Trials

The Safety and Long-Term Clinical Benefit of PCSK9i in STEMI Patients

Start date: November 1, 2022
Phase: Phase 4
Study type: Interventional

Patients with acute coronary syndromes (ACS) have an increased risk of recurrent ischemic events, particularly during the first year following the index event, which is mainly due to unattended risk factors and/ or poor compliance with medications. Lowering low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular morbidity and mortality in patients with atherosclerotic cardiovascular disease (ASCVD), with a magnitude of clinical benefit that is proportional to the reduction in LDL-C levels. Proprotein convertase subtilisin/ kexin type 9 (PCSK9) antibodies have emerged as a new class of drugs that rapidly and effectively lower LDL-C levels up to 77 % of the original value in combination with statins. The primary objective of this study is to confirm the safety and the long-term clinical benefit associated with the use of PCSK9i when combined with statin in patients with ACS-STEMI. The study is an investigator-initiated, prospective, randomized, open label study that will be the first study looking for the safety and the clinical benefit and outcome associated with the use of PCSK9i in ACS-STEMI patients specifically. Internationally, this will be the first trial studying the effect of PCSK9i on patients with acute myocardial infarction (STEMI) in terms of reduction in cholesterol level and reduction in cardiac events rate (re-infarction and cardiac death) after myocardial infarction. This trial will have a significant impact in the management of patients with STEMI, locally and internationally and it will be conducted purely in Qatar. This trial will help to improve the clinical outcome of patients in Qatar in terms of reduction of myocardial reinfarction rate and mortality.

NCT ID: NCT05393882 Not yet recruiting - Clinical trials for Coronary Artery Disease

Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency

Start date: September 1, 2024
Phase:
Study type: Observational [Patient Registry]

This single-centre cross-sectional study aims to ascertain the impact of dyslipidemia on long-term graft patency after coronary artery bypass grafting (CABG).

NCT ID: NCT05347823 Not yet recruiting - Dyslipidemias Clinical Trials

Study of Adherence to Antihypertensive Drugs and Statins by Hair Analysis

INNOVA
Start date: May 15, 2022
Phase:
Study type: Observational

The problem of adherence to long-term therapies has been known for years and occurs substantially in all countries, although with greater severity in developing countries. The investigators designed a prospective open study in which 200 patients followed for hypertension at the centers of the Italian Society of Hypertension (SIIA) adhering to the project will be evaluated on the basis of their clinical characteristics, the presence of comorbidities and the therapeutic scheme in place and will be subjected to hair sampling for the analysis of drugs of interest and their possible metabolites in this matrix. The use of the prescribed drugs is recorded along with the relevant clinical parameters and preliminarily evaluated by application of a questionnaire. At the first visit, patients who have been prescribed continuously in the 3 months preceding the study the same active ingredients will be invited to participate in the study, which involves a hair sampling. They will then be prescribed the same active ingredients according to the same scheme if the blood pressure values are within the recommended limits. When more than one antihypertensive drug is present in the therapeutic scheme, they will be prescribed in a single pill, as recommended. For patients with uncontrolled blood pressure, the therapeutic scheme will be modified with the inclusion of other active ingredients and using drug combinations when possible. Patients treated with statins will continue the treatment according to clinical indication using associations with antihypertensive drugs. Patients will be examined and re-tested 3-4 months after the first visit. The use of prescribed medications will be recorded along with clinical parameters of interest and preliminarily evaluated by application of questionnaires. At each of the two visits, the investigating physician will measure blood pressure using a semi-automatic device The 24-hour blood pressure monitoring will be used. Hair extraction ad UHPLC-QQQ/MS analysis will be performed. Concentrations of active ingredient and any metabolites in the keratin matrix are expressed in ng or fractions of ng/mg.

NCT ID: NCT05297383 Not yet recruiting - Obesity Clinical Trials

Pilot: Combining HIIT and n-3 PUFA Supplementation to Reduce Inflammation and Improve Metabolic Health (HIIT&PUFA)

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The goal of this pilot study is to understand the combined effects of fish oil and exercise in obesity-associated inflammation acutely. We hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and reduce inflammation and metabolic risk.

NCT ID: NCT05295719 Not yet recruiting - Obesity Clinical Trials

Combining HIIT and n-3 PUFA to Reduce Inflammation and Improve Metabolic Health

HIIT&PUFA
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk.

NCT ID: NCT05238012 Not yet recruiting - Clinical trials for Metabolism Disorder, Glucose

Compare the Impact of Xuezhikang and Atorvastatin on Glucose Metabolism in Dyslipidemia Patients With Prediabetes

XTREME
Start date: July 1, 2022
Phase: Phase 4
Study type: Interventional

This study is a prospective, randomized, open-label, multi-center trial. The primary objective of the study is to assess whether XZK 1200mg/d, compared to atorvastatin 20mg/d, has a favorable impact on HbA1c levels at 24 weeks of treatment in dyslipidemia patients with prediabetes