A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effect of Betahistine on Plasma Lipids in Patients Treated With Simvastatin

• Status: Terminated
• Trial end date: 2007-09-01

Summary

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.

• Phase: Phase 2

Details

• Lead Sponsor: OBEcure Ltd.
• Treatments: Betahistine; Simvastatin