Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-03 @ 3:46 AM
Study NCT ID:
NCT00466869
Status:
TERMINATED
Last Update Posted:
2007-09-26
First Post:
2007-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effect of Betahistine on Plasma Lipids in Patients Treated With Simvastatin
Sponsor:
OBEcure Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effect of Betahistine on Plasma Lipids in Patients Treated With Simvastatin
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: