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HypercholesterolemiaPhase 2NCT00466869

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

A Phase 2 study testing Betahistine in people with Hypercholesterolemia, run by OBEcure Ltd. at 2 sites in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
Betahistine
How many people
30 participants
Where
2 sitesIsrael
Study dates
May 2007to Sep 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
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  • 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;
  • Previous malignant disease within 5 years of screening: (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis \& T1]
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x ULN;
  • CPK (creatine phosphokinase) >3 x ULN
  • Hypothyroid patient defined as: TSH > 7.5 mU/l or 5<TSH <7.5 mU/l and total T4< 4.00 mcg/dl (51.5 nmol/l) (regardless if the patient is on replacement therapy or not).
  • Plans on having any surgery (elective or otherwise) during the course of the study;
  • Has uncontrolled hypertension (sitting blood pressure > 160/100 mmHg at screening or randomization).
  • History of asthma;
  • History of peptic ulcers;
  • History of HIV
  • Any other disease or condition which might preclude the patient's regular participation to the study (e.g. other endocrine diseases, acute or chronic infections, known or suspected drug or alcohol abuse or has psychiatric or neurological disorders requiring chronic medications (e.g., antidepressants);
  • Chronic or as needed use of antihistamines;
  • Has not been on a stable treatment regimen with any of the following medications for a minimum of 90 days prior to screening:
  • Hormone replacement therapy;
  • Oral contraceptives;
  • Antihypertensive agents;
  • Metformin;
  • hyroid replacement therapy;
  • Has been treated over the past 60 days, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
  • All prescription or over-the-counter agents taken for the purpose of treating dyslipidemia, including (but not limited to) the following agents:
  • Statins such as Rosuvastatin (Crestor), Fluvastatin (Lescol), Atorvastatin (Lipitor ,Torid), Pravastatin (Pravalip, Pravastatin).
  • Fibrates such as Bezafibrate (Bezafibrate 400 Sr,Norlip) Ciprofibrate Lipanor)
  • Bile acid sequestrant such as Colestipol (Colestid)
  • Cholesterol absorption inhibitor such as Ezetimibe (Ezetrol)
  • Nicotinic acid derivative such as Acipimox (Olbetam)
  • Omega-3-acid such as Triomar, Omacor
  • Over-the-counter hypolipidemic agents (e.g., vitamins, herbal supplements or other alternative remedies);
  • All prescription or over-the-counter agents taken for the purpose of weight reduction, including (but not limited to) the following anti obesity agents:
  • Prescription drugs such as orlistat (Xenical®), sibutramine (Reductil), and phentermine (Razin).
  • Psychotropic/neurological agents including the following:
  • Antipsychotic agents (e.g., Olanzapine, Clozapine, Risperidol, Lithium, etc.).
  • Antiepileptic agents (e.g., Topamax®, Zonegran®, valproate, carbamazepine).
  • Antidepressant agents including the following: monoamine oxidase inhibitors, bupropion (Zyban®), tricyclic antidepressants, and tetracyclic antidepressants; and selective serotonin reuptake inhibitors (e.g., Prozac®, Paxil®, Zoloft®, etc.);
  • Systemic steroids administered by oral, intravenous, or intramuscular route;
  • Drugs that directly affect gastrointestinal motility (e.g., Reglan® and Propulsid®, and chronic [taken for more than 10 days within a 6-month period prior to screening visit 1] macrolide antibiotics such as erythromycin and newer derivatives):
  • Calcitonin (e.g., Miacalcin®);
  • Insulin;
  • α-glucosidase inhibitor (Prandase®);
  • Sulfonylureas (e.g., Amaryl®, Diabitex®, Glibetic®, Gluben®, Gluco- Rite® Novonorm® Orsinon®); Or
  • Meglitinide (e.g. NovoNorm)
  • Rosilitazone (e.g. Avandamet ® Avandia® Rossini®)
  • Receipt of any investigational treatment (drug or device) within 30 days prior to screening;
  • Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site; or
  • Is employed by OBEcure Ltd.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Internal Medicine Department A-Wolfson Medical Center

    Holon

  • Internal Medicine Department A-Meir Medical Center

    Kfar Saba

Other trials in Israel

About this study

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.

Read more

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.

Being tested
Betahistine
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BetahistineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

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

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

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

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

  6. Change in hemoglobin A1c [HbA1c], and fasting plasma glucose [FPG] from baseline (randomization) to Week 4.

  7. Change in Caloric intake and macronutrients intake from baseline (randomization) to Week 4.

  8. Change in body weight from baseline (randomization) to Week 4.

  9. Change in waist circumference from baseline (randomization) to Week 4.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2007 (estimated)
  2. Study startMay 2007
  3. Study completionSep 2007

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00466869
Sponsor's protocol ID
BET203
Status last verified
Aug 2007
First submitted
25 Apr 2007
Last updated
26 Sep 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Betahistine in people with Hypercholesterolemia, run by OBEcure Ltd. at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00466869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2007; AzTrials last refreshed its copy on 31 Oct 2026.

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