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

NCT ID: NCT02226926

Last Updated: 2014-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31

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

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aggrenox

Dipyridamole extended release / Acetylsalicylic acid

Group Type: EXPERIMENTAL

Aggrenox

Intervention Type: DRUG

Persantin Retard

Dipyridamole extended release

Group Type: ACTIVE_COMPARATOR

Persantin Retard

Intervention Type: DRUG

Acetylsalicylic acid

Group Type: ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type: DRUG

Interventions

Aggrenox

Intervention Type: DRUG

Persantin Retard

Intervention Type: DRUG

Acetylsalicylic acid

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9.142

Identifier Type: -

Identifier Source: org_study_id