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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran

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.