Phase 1
Completed N=19
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
Renal Insufficiency, Chronic
Source: ClinicalTrials.gov NCT01711853 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Cmax,ss — 207 ng/mL — p=0.5186
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax,ss |
207 | 0.5186 |
| PRIMARY AUCtau,ss |
2140 | 0.4692 |
Eligibility Criteria
Inclusion criteria
- Male and female patients aged 18 years and older
- 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.
- The single use of either aspirin or Vitamin K Antagonists
- Provision of informed consent.
Exclusion criteria
- Unstable renal function and Creatinin Clearance <15mL/min
- Patients treated with two or more platelet aggregation inhibitors
- Use of or indication for therapeutic heparin
- Patients with prosthetic heart valves
- Haemorrhagic disorder or bleeding diathesis
- Platelet count <100 109/L) at screening or during the last 30 days before screening.
- Participation in another drug trial in the last 30 days before screening.
Data sourced from ClinicalTrials.gov (NCT01711853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.