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Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terbogrel | Active Comparator |
| |
| Terbogrel with Clopidogrel | Experimental |
| |
| Clopidogrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbogrel | Drug |
| ||
| Clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inhibition of platelet aggregation in platelet rich plasma (PRP) | baseline, up to day 17 | |
| Change in thromboxane receptor occupancy (TRO) | baseline, up to day 17 | |
| Change in 6-keto-prostaglandinF-1-alpha | baseline, up to day 17 | |
| Change in thromboxan synthesis inhibition (TSI) | baseline, up to day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of terbogrel | up to day 17 | |
| Number of patients with adverse events | up to day 17 | |
| Change in bleeding time |
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Inclusion Criteria:
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
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
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| ID | Term |
|---|---|
| C112331 | terbogrel |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
|
| baseline, up to day 17 |
| Change in systolic and diastolic blood pressure | baseline, up to day 17 |
| Change in pulse rate | baseline, up to day 17 |
| Number of patients with haematuria | dipstick test | up to day 17 |
| Number of patients with positive Haemoccult test | up to day 17 |
| Number of patients with clinically significant laboratory findings | up to day 17 |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |