Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.

Launched by BOEHRINGER INGELHEIM · Oct 19, 2012

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Male and female patients aged 18 years and older
• • 2. Impaired renal function defined as a stable Cockcroft-Gault and/or actual creatinine clearance between 15-30 ml/min over the last 3 months before study participation.
• • 3. The single use of either aspirin or Vitamin K Antagonists
• • 4. Provision of informed consent.
• Exclusion criteria:
• • 1. Unstable renal function and Creatinin Clearance \<15mL/min
• • 2. Patients treated with two or more platelet aggregation inhibitors
• • 3. Use of or indication for therapeutic heparin
• • 4. Patients with prosthetic heart valves
• • 5. Haemorrhagic disorder or bleeding diathesis
• • 6. Platelet count \<100 109/L) at screening or during the last 30 days before screening.
• • 7. Participation in another drug trial in the last 30 days before screening.