Triple vs. Dual Therapy
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- body mass index between 18 and 27 kg/m2
- Written informed consent
- Non-smoking behaviour
- ...
- body mass index between 18 and 27 kg/m2
- Written informed consent
- Non-smoking behaviour
- Normal findings in medical & bleeding history
- Healthy male subjects; 18 - 40 years of age
Exclusion Criteria
- HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
- Impaired renal function (serum creatinine > 1.3 mg/dl)
- Anaemia (defined as haemoglobin levels < LLN)
- ...
- HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
- Impaired renal function (serum creatinine > 1.3 mg/dl)
- Anaemia (defined as haemoglobin levels < LLN)
- History of thromboembolism
- Regular intake of any medication including OTC drugs and herbals within 2 weeks before IMP administration
- Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol
- Known disorders with increased bleeding risk (e.g. peridontitis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
- Participation in another clinical trial during the preceding 3 weeks
- Known allergy against test agents
- Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis
- Systolic blood pressure above 145 mmHg, diastolic blood pressure above 95 mmHg
- Known coagulation disorders (e.g. haemophilia, von Willebrand´s disease)
- Known sensitivity to common causes of bleeding (e.g. nasal)
- Impaired liver function (AST, ALT, GGT >2 x ULN, Bilirubin >1.5 x ULN)
Summary
- Conditions
- Acute Coronary Syndrome
- Atrial Fibrillation
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
Inclusion Criteria
- body mass index between 18 and 27 kg/m2
- Written informed consent
- Non-smoking behaviour
- ...
- body mass index between 18 and 27 kg/m2
- Written informed consent
- Non-smoking behaviour
- Normal findings in medical & bleeding history
- Healthy male subjects; 18 - 40 years of age
Exclusion Criteria
- HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
- Impaired renal function (serum creatinine > 1.3 mg/dl)
- Anaemia (defined as haemoglobin levels < LLN)
- ...
- HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
- Impaired renal function (serum creatinine > 1.3 mg/dl)
- Anaemia (defined as haemoglobin levels < LLN)
- History of thromboembolism
- Regular intake of any medication including OTC drugs and herbals within 2 weeks before IMP administration
- Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol
- Known disorders with increased bleeding risk (e.g. peridontitis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
- Participation in another clinical trial during the preceding 3 weeks
- Known allergy against test agents
- Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis
- Systolic blood pressure above 145 mmHg, diastolic blood pressure above 95 mmHg
- Known coagulation disorders (e.g. haemophilia, von Willebrand´s disease)
- Known sensitivity to common causes of bleeding (e.g. nasal)
- Impaired liver function (AST, ALT, GGT >2 x ULN, Bilirubin >1.5 x ULN)
Tracking Information
- NCT #
- NCT02080858
- Collaborators
- Not Provided
- Investigators
- Not Provided
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