Effects of Acetylsalicylic Acid Compared With the Combination of Acetylsalicylic Acid + Modified-release Dipyridamole on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers

NCT02268773 | Completed Phase 1

• 1 other identifier: 9.130
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of thromboxane B2 formation

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Absolute serum thromboxane B2 level

  At day 3 after start of drug administration

Secondary Outcomes (8)

• Change in platelet aggregation

  At day 3 after start of drug administration

• Change in time course of inhibition of serum thromboxane B2

  Pre-dose, up to day 14 after start of drug administration

• Change in time course of inhibition of platelet aggregation

  Pre-dose, up to day 14 after start of drug administration

• Changes from baseline in vital signs

  Pre-dose, up to 14 days after first drug administration

• Changes from baseline in laboratory tests

  Pre-dose, up to 14 days after first drug administration

Study Arms (2)

Acetylsalicylic acid low dose with Asasantin®

EXPERIMENTAL

Drug: Asasantin®; Drug: Acetylsalicylic acid low dose

Acetylsalicylic acid high dose

ACTIVE COMPARATOR

Drug: Acetylsalicylic acid high dose

Interventions

Asasantin® DRUG

Also known as: modified-release dipyridamole

Acetylsalicylic acid low dose with Asasantin®

Acetylsalicylic acid low dose DRUG

Acetylsalicylic acid low dose with Asasantin®

Acetylsalicylic acid high dose DRUG

Acetylsalicylic acid high dose

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy volunteers aged 20 to 50 years
• Clinically normal medical history
• Clinically normal findings on physical examination
• Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent
• Willing to give informed consent prior to participation in the trial (i.e. prior to any trial-specific procedures)

You may not qualify if:

• Any clinically significant disease. (A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject's ability to participate in the study)
• Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings
• Serum glutamate-oxaloacetate transferase (SGOT) or serum glutamate-pyruvate transferase (SGPT) \> 80 IU/L, bilirubin \> 34 µmol/L or creatinine \> 176 µmol/L regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
• Use of dipyridamole, aspirin or any non-steroidal anti-inflammatory agent (NSAID) during the previous two weeks
• Active peptic ulceration or history of peptic ulcer disease
• Known history of or suspected hypersensitivity to dipyridamole, aspirin, any NSAID or any other component of the test drugs
• History of any bleeding disorders
• History of cerebral haemorrhage
• Resting, seated blood pressure less than 90/60 mmHg
• Participation in any drug clinical trial within sixteen weeks prior to the start of the trial
• Any indication of current or previous abuse of alcohol, solvents or drugs
• Any chronic illness
• Asthma
• Requirement for any other medication one month before or during the study
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile) were to be excluded

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 20, 2014
• Study Start: January 1, 2000
• Primary Completion: May 1, 2000
• Last Updated: October 20, 2014

Record last verified: 2014-10