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

NCT00466869 | Terminated Phase 2

• 1 other identifier: BET203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• Change in Total Cholesterol from baseline (randomization) to Week 4.

• Change in Triglycerides l from baseline (randomization) to Week 4.

• Change in High density lipoprotein (HDL-C) from baseline (randomization) to Week 4.

• Change in Total cholesterol to HDL-C ratio from baseline (randomization) to Week 4.

• Change in ApoB from baseline (randomization) to Week 4.

Interventions

Betahistine DRUG

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent;
• Male or female subjects 30 to 75 years of age;
• Treated with Simvastatin (Simovil,C500,Simvacor,Simvastatin-Teva,Simvaxon)in dose that does not exceed 40 mg/day.
• Has been on a stable (unchanged) dose of Simvastatin for at least 3 months prior to screening;
• If female, is nonlactating, has a negative urine pregnancy test result, and does not plan on becoming pregnant during the study, or not of childbearing potential (hysterectomy or tubal ligation at least 6 months prior to randomization or post-menopausal for 1 year); if of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice or be willing to continue to practice appropriate birth control (such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire study duration
• Consistent LDL-cholesterol values, taken at Visit 1 and 2 (screening visit 1 and screening visit 2), without deviations of more than 12% of each value from their mean.
• Patients should keep a stable diet and constant exercise activities during the last 3 months, as per the patients statements.
• Patients are compliant (taking \> 80%) with study medication during the screening period.

You may not qualify if:

• Has uncontrolled hyperlipidemia (triglycerides \[TG\] \>=300mg/dL or low-density lipoprotein cholesterol \[LDL-C\] \>160 mg/dL or \< 100mg/dL
• Has recently started or plans on starting a smoking cessation program;
• Has a BMI of less than 18.5 kg/m2 or higher than 40 kg/m2
• Has had a major change in daily physical activity (e.g., initiation of an exercise program) or started a weight loss program within 90 days prior to screening;
• Is unwilling or unable to participate in a dietary assessment as part of the study;
• Has a clinically significant history or presence of any of the following conditions:
• History of myocardial infarction, cerebrovascular accident, stroke, unstable angina , percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG), cardiac valve abnormalities that requires the use of anticoagulants or SBE prophylaxis, within the six months prior to the screening visit 1.
• Congestive heart failure (NYHA class 3 or 4).
• Significant arrhythmia or conduction disturbances (e.g.: second or third degree AV block without a cardiac pacemaker, multiple multifocal ventricular ectopic beats).
• History of pancreatitis and/or serum amylase \>2xULN) in addition to clinical signs of pancreatitis.
• History of gastro-intestinal disease (e.g. Crohn's disease) which could result in impaired absorption of the study drug.
• Type 1 diabetes mellitus;
• Treated Type 2 diabetes mellitus ( metformin monotherapy and/or diet are allowed ) with HbA1c \>8%;
• Severe type 2 diabetes with history of ketoacidosis or diabetic ulcers, or presence of retinopathy, neuropathy, or nephropathy;
• Renal insufficiency defined as a serum creatinine\>=1.5 mg/dL (133 µmol/L) at screening;

Sponsors & Collaborators

• OBEcure Ltd.: lead

Study Sites (2)

Internal Medicine Department A-Wolfson Medical Center

Holon, Israel

Location

Internal Medicine Department A-Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yaffa Beck, Dr.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: May 1, 2007
• Study Completion: September 1, 2007
• Last Updated: September 26, 2007

Record last verified: 2007-08

Locations

IL (2)