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OpenTrials
Completed

NCT Number: NCT02268773

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

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

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Key information

Conditions

Age range

20 year–50 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

  • 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

Treatment and study plan

Asasantin®

Drug

Other names: modified-release dipyridamole

Acetylsalicylic acid low dose

Drug

Acetylsalicylic acid high dose

Drug

Primary outcomes

  1. Absolute serum thromboxane B2 level

    Time frame: At day 3 after start of drug administration

Secondary outcomes

  1. Change in platelet aggregation

    Time frame: At day 3 after start of drug administration

    measured ex-vivo

  2. Change in time course of inhibition of serum thromboxane B2

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

  3. Change in time course of inhibition of platelet aggregation

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

  4. Changes from baseline in vital signs

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

    systolic and diastolic blood pressure, pulse rate

  5. Changes from baseline in laboratory tests

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

  6. Changes from baseline in physical examination

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

  7. Changes from baseline in 12-lead ECG

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

  8. Number of patients with adverse events

    Time frame: Up to 14 days after start of drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Two-period, Cross-over Trial to Compare the Effects of Acetylsalicylic Acid (75 mg/Day) With the Combination of Acetylsalicylic Acid (25 mg) + Modified-release Dipyridamole (200 mg) (bd) on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers

Important dates

Study start
2000
Primary completion
2000
First posted
Oct 20, 2014
Registry last updated
Oct 20, 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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