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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Acetylsalicylic acid; Drug: Aggrenox; Drug: Persantin Retard

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dipyridamole plasma levels	by High Performance Liquid Chromatography (HPLC)	up to day 10

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (Actual): September 1, 2000

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): August 27, 2014
• Last Update Submitted That Met QC Criteria: August 26, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Phosphodiesterase Inhibitors; Aspirin; Dipyridamole; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.142