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OpenTrials
Completed

NCT Number: NCT02226926

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

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aggrenox

Drug

Persantin Retard

Drug

acetylsalicylic acid

Drug

Primary outcomes

  1. VASP-Ser239 / VASP-Ser157-phosphorylation

    Time frame: 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 outcomes

  1. Change in Dipyridamole plasma levels

    Time frame: up to day 10

    by High Performance Liquid Chromatography (HPLC)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2000
Primary completion
2000
First posted
Aug 27, 2014
Registry last updated
Aug 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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