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CompletedNCT02226926Updated Aug 27, 2014

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

A Phase 1 interventional study of Aggrenox and Persantin Retard in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-27.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Aggrenox

    Dipyridamole extended release / Acetylsalicylic acid

    Drug: Aggrenox

  • Active comparator
    Persantin Retard

    Dipyridamole extended release

    Drug: Persantin Retard

  • Active comparator
    Acetylsalicylic acid

    Drug: Acetylsalicylic acid

Interventions

  • DrugAggrenox
  • DrugPersantin Retard
  • DrugAcetylsalicylic acid
06

What researchers measure

Primary outcomes

  1. VASP-Ser239 / VASP-Ser157-phosphorylation

    induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot)

    Time frame: up to day 10

Secondary outcomes

  1. Change in Dipyridamole plasma levels

    by High Performance Liquid Chromatography (HPLC)

    Time frame: up to day 10

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02226926
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Aug 27, 2014
Start date
Jul 2000
Primary completion
Sep 2000
Last update
Aug 27, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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