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OpenTrials
Completed

NCT Number: NCT02222987

Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects

Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

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

  • Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • Healthy male subjects
  • Age >= 18 and <= 45 years
  • Broca >= -20% and <= +20 %

Exclusion criteria

  • Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Chronic or relevant acute infections
  • History of
  • allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • any bleeding disorder including prolonged or habitual bleeding
  • other hematologic disease
  • cerebral bleeding (e.g. after car accident)
  • commotio cerebri
  • Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
  • Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within 2 months days prior to administration or during the trial
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
  • Alcohol (> 60 g/day) abuse
  • Drug abuse
  • Blood donation within 1 month prior to administration or during the trial
  • Excessive physical activities within 5 days prior to administration or during the trial
  • Any laboratory value outside the reference range of clinical relevance
  • History of any familial bleeding disorder
  • Thrombocytes < 150000/µl

Treatment and study plan

Terbogrel

Drug

clopidogrel

Drug

Primary outcomes

  1. Change in inhibition of platelet aggregation in platelet rich plasma (PRP)

    Time frame: baseline, up to day 17

  2. Change in thromboxane receptor occupancy (TRO)

    Time frame: baseline, up to day 17

  3. Change in 6-keto-prostaglandinF-1-alpha

    Time frame: baseline, up to day 17

  4. Change in thromboxan synthesis inhibition (TSI)

    Time frame: baseline, up to day 17

Secondary outcomes

  1. Plasma levels of terbogrel

    Time frame: up to day 17

  2. Number of patients with adverse events

    Time frame: up to day 17

  3. Change in bleeding time

    Time frame: baseline, up to day 17

  4. Change in systolic and diastolic blood pressure

    Time frame: baseline, up to day 17

  5. Change in pulse rate

    Time frame: baseline, up to day 17

  6. Number of patients with haematuria

    Time frame: up to day 17

    dipstick test

  7. Number of patients with positive Haemoccult test

    Time frame: up to day 17

  8. Number of patients with clinically significant laboratory findings

    Time frame: up to day 17

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Oral Doses of 100 mg Terbogrel Bid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.

Important dates

Study start
1999
Primary completion
1999
First posted
Aug 22, 2014
Registry last updated
Aug 22, 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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