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

NCT ID: NCT02268773

Last Updated: 2014-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acetylsalicylic acid low dose with Asasantin®

Group Type: EXPERIMENTAL

Asasantin®

Intervention Type: DRUG

Acetylsalicylic acid low dose

Intervention Type: DRUG

Acetylsalicylic acid high dose

Group Type: ACTIVE_COMPARATOR

Acetylsalicylic acid high dose

Intervention Type: DRUG

Interventions

Asasantin®

Intervention Type: DRUG

Acetylsalicylic acid low dose

Intervention Type: DRUG

Acetylsalicylic acid high dose

Intervention Type: DRUG

Other Intervention Names

modified-release dipyridamole

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• Previous participation in the randomisation phase of this clinical trial

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9.130

Identifier Type: -

Identifier Source: org_study_id