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Trial record 4 of 86 for:    ASPIRIN AND thromboxane

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

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ClinicalTrials.gov Identifier: NCT02268773
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 17, 2014
First Posted Date  ICMJE October 20, 2014
Last Update Posted Date October 20, 2014
Study Start Date  ICMJE January 2000
Actual Primary Completion Date May 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
Absolute serum thromboxane B2 level [ Time Frame: At day 3 after start of drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
  • Change in platelet aggregation [ Time Frame: At day 3 after start of drug administration ]
    measured ex-vivo
  • Change in time course of inhibition of serum thromboxane B2 [ Time Frame: Pre-dose, up to day 14 after start of drug administration ]
  • Change in time course of inhibition of platelet aggregation [ Time Frame: Pre-dose, up to day 14 after start of drug administration ]
  • 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
  • Changes from baseline in laboratory tests [ Time Frame: Pre-dose, up to 14 days after first drug administration ]
  • Changes from baseline in physical examination [ Time Frame: Pre-dose, up to 14 days after first drug administration ]
  • Changes from baseline in 12-lead ECG [ Time Frame: Pre-dose, up to 14 days after first drug administration ]
  • Number of patients with adverse events [ Time Frame: Up to 14 days after start of drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Asasantin®
    Other Name: modified-release dipyridamole
  • Drug: Acetylsalicylic acid low dose
  • Drug: Acetylsalicylic acid high dose
Study Arms  ICMJE
  • Experimental: Acetylsalicylic acid low dose with Asasantin®
    Interventions:
    • Drug: Asasantin®
    • Drug: Acetylsalicylic acid low dose
  • Active Comparator: Acetylsalicylic acid high dose
    Intervention: Drug: Acetylsalicylic acid high dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2014)
27
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02268773
Other Study ID Numbers  ICMJE 9.130
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP