Single center, exploratoric, open-label study to investigate the precise mechanism of action of Cavinton (vinpocetin)

• Conditions: endothel dysfunction and peripherial circulation

• Registration Number: EUCTR2006-004641-42-HU
• Lead Sponsor: Gedeon Richter Plc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•CT or MRI verified stroke due to large-vessel atherosclerosis according to TOAST criteria, which occurred more than 6 months before enrolment.
•Age between 35 and 75 years (both males and females).
•18 kg/m2 = BMI = 35 kg/m2 (and the minimal body weight is 40 kg)
•Signed Inform Consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Ischaemic or haemorrhagic stroke due to non-large-vessel atherosclerosis according to TOAST criteria.
•Uncontrolled hypertension (systolic > 180 Hgmm, diastolic > 110 Hgmm).
•If QTc > 500 msec.
•Any clinically significant abnormality in clinical laboratory tests. Screening haematology and biochemistry laboratory tests must be within defined limits including full blood count within the normal range (or not clinically significantly abnormal), liver enzymes not exceed three times the upper limit of normal range, alkaline phosphatase, bilirubin not exceed twice the upper limit of normal range.
•Having received the investigational product (vinpocetin) during 1 month prior to the study without 1 month long wash-out period.
•Current treatment with drugs having cognitive effect in the central nervous system (for example: piracetam, nicergolin, pyritinol, metylphenidate) with patients unable or unwilling to be withdrawn from this medication before the trial.
•If the patient’s cardiovascular or metabolic medications were changed during 1 month prior to the study.
•Known hypersensitivity to vinpocetin or lactose intolerance.
•Severe physical or mental concomitant disorder that might confound the conduct or result of the trial.
•Any kind of acute or chronic disorder, which can influence the level of the inflammatory markers.
•Lactating or pregnant women or women of child-bearing potential without appropriate contraceptive treatment.
•Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study or to cooperate on the necessary level.
•Evidence of an uncooperative attitude.
•Patients who have participated in a study of an investigational drug or device within 3 months of this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To investigate the safety and tolerability of the study medications.;Main Objective: To investigate the effect of Cavinton (vinpocetin) injection and tablet to the endothelium and peripherial circulation and to explore more about the precise mechanism of action of vinpocetin.;Primary end point(s): The change from baseline at visit 2 and visit 3 and the change between two consecutive visits will be analysed by ANOVA and post hoc analysis will be performed to compare the corresponding visits.