Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Aggrenox; Drug: Persantin Retard; Drug: Acetylsalicylic acid

• Registration Number: NCT02226926
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma levels

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2000-09
• Status Verified: 2014-08
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-26
• Last Update Submitted: 2014-08-26
• Study First Posted: 2014-08-27
• Last Update Posted: 2014-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Healthy females/males
• Age range from 18 to 60
• Volunteers will have given their written informed consent in accordance with local ethics committee and local legislation

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Exclusion Criteria

• Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
• Known history of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Drug intake with long half-life (> 24 hours), < 1 month prior to administration or during the trial
• Volunteers received any other drugs which might influence the results of the trial, < 10 days prior to administration or during the trial
• Participation in another study with an investigational drug, < 1 month prior to administration or during the trial
• Smoking more than 15 cigarettes or 4 cigars or 4 pipes/day
• Drinking more than 60 g of alcohol per day
• Unable to refrain from excessive consumption of methylxanthine containing drinks or food
• Drug addiction
• Blood donation (> 400 ml), < 4 weeks prior to administration or during the trial
• Participation in excessive physical activities, < 5 days prior to administration or during the trial

For female volunteers:

• Pregnancy
• Positive pregnancy test
• No adequate contraception (acceptable: oral contraceptives, condoms, etc.)
• Lactation period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aggrenox	Aggrenox	Dipyridamole extended release / Acetylsalicylic acid
Persantin Retard	Persantin Retard	Dipyridamole extended release
Acetylsalicylic acid	Acetylsalicylic acid	-

Primary Outcome Measures

Name	Time	Method
VASP-Ser239 / VASP-Ser157-phosphorylation	up to day 10	induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot)

Secondary Outcome Measures

Name	Time	Method
Change in Dipyridamole plasma levels	up to day 10	by High Performance Liquid Chromatography (HPLC)