Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effect of Betahistine on Plasma Lipids in Patients Treated With Simvastatin
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:
- Betahistine 24 mg BID (48 mg/day total), or
- Matching placebo BID.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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