Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT00466869
Brief 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.
Study:
NCT00466869
Study Brief:
Protocol Section:
NCT00466869