NCT03696940Unknown3 期
Estudio clínico Fase III Para Evaluar la Eficacia terapéutica en Pacientes Mexicanos Con Dislipidemia Mediante el Uso vía Oral de L-Carnitina + Atorvastatina Comparado Con Atorvastatina
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy of experimental treatment by the change in Cholesterol LDL
研究概览
简要总结
Clinical Trial Phase III, experimental, simple blind, randomized with two treatment groups, multicentric, longitudinal, to evaluate the therapuetic efficacy to dislipydemias in mexican adult population. This trial includes homogeneus populations that could be comparable by their disease condition, biologic characteristics and sociodemographics characteristics.
2 Treatment groups: Experimental Group: Oral Administration of L-carnitine (1g) + Oral Atorvastatin (20mg), every 24 hours for 6 months.
Active control group: Oral Administration of Atorvastatin 20mg every 24 hours for 6 months.
Sample Size: 120 subjects, females or males between 35 to 75 years old. Laboratory tests: Hematic biometry, quimical blood components, electrocardiogram and pregnancy urinary test.
详细描述
General objectives:
Evaluate the therapeutic efficacy in Mexican adults with dyslipidemia through the oral route use of L-carnitine + atorvastatin in comparison with the use of Atorvastatin, after six months of treatment.
Evaluate the safety of the medicines under study.
Hypothesis:
The combined use of L-carnitine + atorvastatin offers therapeutic superiority with respect to the use of atorvastatin as treatment to reduce the percentage of C-LDL in patients with dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Simple Blinded
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mexicans between 35 and 75 years of age.
- •Gender indistinct.
- •Patient with abnormal lipid profile considered as serum levels of Cholesterol LDL of 100mg/dl or greater, obtained by laboratory parameters.
- •Not being under pharmacologic treatment to manage its dyslipidemia or accept to suspend current treatment and be evaluated for inclusion in the next 3 weeks starting on the day of initial evaluation.
- •Women in fertile stage with a safe, hormonal-free family planning method. A safe planning method includes surgical methods in women, intrauterine device that doesn't release progestines and use of preservative in all their sexual relations.
- •Women in fertile stage who don't wish to become pregnant during their participation in the study.
- •Post-menopause women or with hysterectomy history.
- •Have a fixed and/or mobile telephone and accept to receive calls from the site for study processes.
- •Grant their duly informed consent.
排除标准
- •Subject lacking the mental capacity to understand the processes which imply their participation in the study and thus, not capable of granting their participation in a voluntary manner
- •History of hypersensitivity to the medicines being studied.
- •Daily intake of at least 240 mL of grape juice or sporadic ingestion of 1 liter.
- •Potentially fertile women without a safe family planning method, who wish to become pregnant during the study, are already pregnant or in lactation period.
- •Having on Globorisk scale for Mexicans, or as an associated risk factor, a high stratification for cardiovascular risk.
- •Basal laboratory values with elevation of ALT 1.5 times larger than the upper limit considered normal according to international units.
- •Basal laboratory values with elevation of CPK not attributable to physical activity.
- •Subjects who are under anticoagulant treatment, suffer from coagulation disorders, or any circumstance which contraindicates the taking of a blood.
- •History of acute myocardial infarction, unstable angina, some confirmed coronopathy, arrhythmias, congestive cardiac failure or cerebrovascular disease.
- •History of muscular conditions of the genetic type or of rhabdomyolysis in the patient or first degree relative.
- •History or diagnose of congenital hepatic disorders, chronic infection by hepatitis virus, hepatitis with fatty liver, alcoholic hepatitis, primary biliary cirrhosis, primary sclerosis, cholangitis or hepatic failure.
- •History or diagnose of congenital renal disorders, chronic renal failure, acute renal damage or nephritic syndrome.
- •History of infection by Human Immunodeficiency Virus.
- •History of Acute or Chronic Pancreatitis.
- •History of the following endocrine diseases: non controlled Diabetes Mellitus, lipodystrophy, thyroid disorders, Cushing Syndrome and or Polycystic Ovary Syndrome.
- •Diseases which compromise immunity such as Systemic Lupus Erythematous, Rheumatoid Arthritis, Antiphospholipid Antibodies Syndrome or Psoriasis.
- •Diseases by deposit such as Gaucher Disease, disease by glycogen deposit, Tay Sachs juvenile disease or Niemann Pick Disease.
- •Diagnose of Kawasaki Disease, Werner Syndrome, intermittent acute Porphyria, Idiopathic Hyperkalemia or Klinefelter Syndrome
- •Suffer from Idiopathic Hyperkalemia, Klinefelter Syndrome, Werner Syndrome, Kawasaki Disease or Porphyria.
- •History of epilepsy.
- •History or diagnose of alcoholism.
- •Intake of more than 20 grams of alcohol per day.
- •User of marihuana.
- •User of illegal drugs.
- •Intake of medicines with pharmacologic interaction which increase or decrease the efficacy of L Carnitine and or atorvastatin or alter the lipids in blood such as Erythromycin, Telithromycin and Clarithromycin. Azole antifungi as Ketoconazole, Itraconazole, Fluconazole and Nefazodone. Quercetin, Amiodarone, Aprepitant, Cimetidine, Ciprofloxacin, Cyclosporine, Diltiazem, Imatinib, Echinacea, Enoxacin, Ergotamine, Metronidazole, Mifepristone, Tofisopam, Gestodene, Verapamil, Mibefradil, Fluoxetine, Phenobarbital, Carbamazepine, Phenytoin, Rifampin, Modafinil, Glucocorticoids, Felbamate, Rosiglitazone, Griseofulvin, Pioglitazone, Gemfibrozil, Clofibrate, Fenofibrate, Niacin, Nefazodone, Cholestyramine, Colchicine, Colestipol, Primidone, Topiramate, Troglitazone, Rifabutin, Digoxin, Thiazides, anabolic Steroids, Progestogens, Estrogens, Danazol, Amiodarone, fibric Acid, docosahexaenoic acid, Isotretinoine, Immunosuppressives, protease inhibitors of HIV or of the Hepatitis C Virus, Inhibitors of the cotransport of sodium glucose, Tamoxifen, Raloxifene, non selective Beta blockers, biliary acid sequestrants, asparginase, Sirolimus and Interferon.
- •Patients who have been diagnosed with terminal conditions.
- •Patients with recent Cancer diagnose or undergoing any type of therapy for same.
- •Patients who have suffered skin cancer not of the melanoma type and have been cured and haven't been on treatment for at least 1 year before the start of their participation in the study may enter.
- •Patients under lipid lowering treatment and who, because of their clinical condition aren't candidates to the period of lavage or detoxification; or well reject it.
- •Being participating in another clinical trial or having concluded their participation in the 30 days previous to beginning their participation in this study.
- •Any other which, at the Investigator's criteria, puts at risk the safety of the participant and or interferes with the results of the study.
研究组 & 干预措施
Experimental Group
Experimental
2 tablets of: L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg
干预措施: L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg (Drug)
Control Group
Active Comparator
2 tablets of: Atorvastatin 10 mg
干预措施: Atorvastatin 10mg (Drug)
结局指标
主要结局
Efficacy of experimental treatment by the change in Cholesterol LDL
时间窗: 6 months
Evaluate the change of atorvastatin + l-carnitine vs. atorvastatin alone for dyslipidemia, through change of C-LDL in mg/dl
次要结局
- Efficacy of experimental treatment by the change in Total serum Cholesterol(6 months)
- Incidence of Treatment-Emergent Adverse Events (safety and tolerability)(6 months)
- Efficacy of experimental treatment by the change in Cholesterol HDL(6 months)
- Efficacy of experimental treatment by the change in Cholesterol no-HDL(6 months)
- Efficacy of experimental treatment by the change in Triglycerides(6 months)
研究者
研究点 (1)
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