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

Phase 1

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: Dabigatran Etexilate

• Registration Number: NCT01711853
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-22
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-12-19
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-09
• Last Update Submitted: 2015-01-09
• Results First Posted: 2015-01-13
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dabigatran Etexilate	Dabigatran Etexilate	patient to receive a capsule containing 75 mg of dabigatran etexilate

Primary Outcome Measures

Name	Time	Method
Cmax,ss	-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h	Maximum concentration of Dabigatran etexilate in plasma at steady state was measured.; The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration.
AUCtau,ss	-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h	Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured.; The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration.

Trial Locations

Locations (1)

1160.166.31001 Boehringer Ingelheim Investigational Site; 🇳🇱 Leiden, Netherlands