Clinical Trial to Evaluate the Efficacy of a Dyslipidemic Therapy in Mexican Population
赞助:
Laboratorios Grossman, S.A.
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 18, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | May 28, 2018 | ||
| 预计主要完成日期 | December 31, 2018 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Efficacy of experimental treatment by the change in Cholesterol LDL[ Time Frame: 6 months ] Evaluate the change of atorvastatin + l-carnitine vs. atorvastatin alone for dyslipidemia, through change of C-LDL in mg/dl |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Clinical Trial to Evaluate the Efficacy of a Dyslipidemic Therapy in Mexican Population | ||
| 正式标题 ICMJE | 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 | ||
| 简要概况 | 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. |
||
| 详细说明 | 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. The combination of L-carnitine + atorvastatin shows fewer incidences in the presence of adverse events attributable to the medicine in comparison to the use of atorvastatin as mono-therapy, in the treatment of dyslipidemia patients. Design: Phase III clinical assay, experimental randomized with two treatment, multi-centered, longitudinal, to evaluate the therapeutic efficacy in dyslipidemias of Mexican adults. Material and Methods: Sample Size 120 subjects will be included. Inclusion Criteria Mexicans between 35 and 75 years of age. Gender indistinct. Patient with abnormal lipid profile considered as serum levels of C-LDL of 100mg/dl or greater obtained by laboratory parameters. Not under pharmacologic treatment to handle their dyslipidemia or accepting to suspend their current treatment and be evaluated for their inclusion in the next 3 weeks starting on the day of the 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. Exclusion Criteria 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 240ml 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 anti-coagulant 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 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 20g 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: Macrolide antibiotics: Erythromycin, Telithromycin and Clarithromycin. Azole anti-fungi: 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 co-transport 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 same. Been 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. Medicine L-Carnitine, Atorvastatin Dose L-Carnitine 1 g + Atorvastatin 20 mg daily for 6 months and Atorvastatin 20 mg daily for 6 months Efficacy criteria: The efficacy of the combined treatment vs. atorvastatin in mono-therapy for dyslipidemia will be compared, through evaluation of the variability of the biochemical parameters at the start and end of the study. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 3 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Longitudinal 盲法: Interventional 盲法描述:Simple Blinded 主要目的: Treatment |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Active, not recruiting | ||
| 预计入组 ICMJE |
120 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | January 31, 2019 | ||
| 预计主要完成日期 | December 31, 2018 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 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. Exclusion Criteria: - 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. | ||
| 性别 |
|
||
| 年龄 | 最小年龄：35 Years ，最大年龄：75 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Mexico | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | ， | ||
| 研究赞助商 ICMJE | Laboratorios Grossman, S.A. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | |||
| 验证日期 | October 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号