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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Notify MeKey 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
Persantin Retard
Drugacetylsalicylic acid
DrugPrimary outcomes
-
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
-
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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