E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
endothel dysfunction and peripherial circulation |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety and tolerability of the study medications. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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nervous system (for example: piracetam, nicergolin, pyritinol, metylphenidate) with patients unable or unwilling to be withdrawn from this medication before the trial.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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is when the last patient completed the follow-up visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |