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

NCT02226926 | Completed Phase 1

• 1 other identifier: 9.142
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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)

  up to day 10

Secondary Outcomes (1)

• Change in Dipyridamole plasma levels

  up to day 10

Study Arms (3)

Aggrenox

EXPERIMENTAL

Dipyridamole extended release / Acetylsalicylic acid

Drug: Aggrenox

Persantin Retard

ACTIVE COMPARATOR

Dipyridamole extended release

Drug: Persantin Retard

Acetylsalicylic acid

ACTIVE COMPARATOR

Drug: Acetylsalicylic acid

Interventions

Aggrenox DRUG

Aggrenox

Persantin Retard DRUG

Persantin Retard

Acetylsalicylic acid DRUG

Acetylsalicylic acid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Aspirin, Dipyridamole Drug Combination; Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dipyridamole; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: July 1, 2000
• Primary Completion: September 1, 2000
• Last Updated: August 27, 2014

Record last verified: 2014-08