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About
This is a randomized, double-blind, placebo-controlled, two-to three center study. The study will consist of 2 treatment groups (Betahistine 48 mg/day or matching placebo). Approximately 30 subjects (15 per treatment group) will be randomized into this 6-week study.
A single blinded placebo treated period of up to 14 days will be used to determine subjects suitability for inclusion in the trial.
In order that a patient will be defined as valid for inclusion in the study, patients should be able to present consistent LDL-C values, taken prior to randomization (at screening visit 1 and screening visit 2), without deviation of more than 12% of each value from their mean.
Within one week from the second screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following treatment groups:
Double-blind treatment will continue for 4 weeks. Study medication (betahistine and/or matching placebo) will be administered BID (before lunch and before dinner).
During the study, subjects will undergo dietary assessment.
The primary efficacy parameter is change in LDL-C from baseline (randomization) to Week 4 and the percentage of patients that reduce their LDL-C by 10% or more.
Enrollment
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Inclusion criteria
Exclusion criteria
Has uncontrolled hyperlipidemia (triglycerides [TG] >=300mg/dL or low-density lipoprotein cholesterol [LDL-C] >160 mg/dL or < 100mg/dL
Has recently started or plans on starting a smoking cessation program;
Has a BMI of less than 18.5 kg/m2 or higher than 40 kg/m2
Has had a major change in daily physical activity (e.g., initiation of an exercise program) or started a weight loss program within 90 days prior to screening;
Is unwilling or unable to participate in a dietary assessment as part of the study;
Has a clinically significant history or presence of any of the following conditions:
Has not been on a stable treatment regimen with any of the following medications for a minimum of 90 days prior to screening:
Hormone replacement therapy;
Oral contraceptives;
Antihypertensive agents;
Metformin;
hyroid replacement therapy;
Has been treated over the past 60 days, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
All prescription or over-the-counter agents taken for the purpose of treating dyslipidemia, including (but not limited to) the following agents:
All prescription or over-the-counter agents taken for the purpose of weight reduction, including (but not limited to) the following anti obesity agents:
Prescription drugs such as orlistat (Xenical®), sibutramine (Reductil), and phentermine (Razin).
Psychotropic/neurological agents including the following:
Antipsychotic agents (e.g., Olanzapine, Clozapine, Risperidol, Lithium, etc.).
Antiepileptic agents (e.g., Topamax®, Zonegran®, valproate, carbamazepine).
Antidepressant agents including the following: monoamine oxidase inhibitors, bupropion (Zyban®), tricyclic antidepressants, and tetracyclic antidepressants; and selective serotonin reuptake inhibitors (e.g., Prozac®, Paxil®, Zoloft®, etc.);
Systemic steroids administered by oral, intravenous, or intramuscular route;
Drugs that directly affect gastrointestinal motility (e.g., Reglan® and Propulsid®, and chronic [taken for more than 10 days within a 6-month period prior to screening visit 1] macrolide antibiotics such as erythromycin and newer derivatives):
Calcitonin (e.g., Miacalcin®);
Insulin;
α-glucosidase inhibitor (Prandase®);
Sulfonylureas (e.g., Amaryl®, Diabitex®, Glibetic®, Gluben®, Gluco- Rite® Novonorm® Orsinon®); Or
Meglitinide (e.g. NovoNorm)
Rosilitazone (e.g. Avandamet ® Avandia® Rossini®)
Receipt of any investigational treatment (drug or device) within 30 days prior to screening;
Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site; or
Is employed by OBEcure Ltd.
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Data sourced from clinicaltrials.gov
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