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Sponsored by: |
OBEcure Ltd. |
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Information provided by: | OBEcure Ltd. |
ClinicalTrials.gov Identifier: | NCT00466869 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia |
Drug: Betahistine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effect of Betahistine on Plasma Lipids in Patients Treated With Simvastatin |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Study Completion Date: | September 2007 |
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Has a clinically significant history or presence of any of the following conditions:
All prescription or over-the-counter agents taken for the purpose of treating dyslipidemia, including (but not limited to) the following agents:
Israel | |
Internal Medicine Department A-Wolfson Medical Center | |
Holon, Israel | |
Internal Medicine Department A-Meir Medical Center | |
Kfar Saba, Israel |
Study Chair: | Yaffa Beck, Dr. | Unaffiliated |
Study ID Numbers: | BET203 |
Study First Received: | April 25, 2007 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00466869 |
Health Authority: | Israel: Ethics Commission; Israel: Ministry of Health |
Metabolic Diseases Hyperlipidemias Simvastatin Histamine phosphate Betahistine |
Metabolic disorder Hypercholesterolemia Dyslipidemias Histamine Lipid Metabolism Disorders |
Antimetabolites Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Antilipemic Agents Physiological Effects of Drugs Histamine Agents |
Enzyme Inhibitors Cardiovascular Agents Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Histamine Agonists Therapeutic Uses |