Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease. (NCT NCT01711853)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

19 participants

Primary outcome timeframe

-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

Results posted on

2015-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Dabigatran 75 mg Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Overall Study STARTED	19
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dabigatran 75 mg Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Overall Study Not treated	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabigatran 75 mg n=16 Participants Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Age, Continuous	72.7 years STANDARD_DEVIATION 7.6 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants

PRIMARY outcome

Timeframe: -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

Population: Pharmacokinetic set (PKS) which included all treated subjects that provided at least 1 observation for at least 1 primary pharmacokinetic endpoint without important protocol violations with respect to the evaluation of the pharmacokinetic endpoints and with predose values not greater than 5% of Cmax.

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.

Outcome measures

Outcome measures
Measure	Dabigatran 75 mg n=15 Participants Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Cmax,ss	207 ng/mL Geometric Coefficient of Variation 53.9

PRIMARY outcome

Timeframe: -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

Population: PKS

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.

Outcome measures

Outcome measures
Measure	Dabigatran 75 mg n=15 Participants Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
AUCtau,ss	2140 ng*h/mL Geometric Coefficient of Variation 51.9

Adverse Events

Dabigatran 75 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dabigatran 75 mg n=16 participants at risk Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Injury, poisoning and procedural complications Nail injury	6.2% 1/16 • Up to Day 11
Injury, poisoning and procedural complications Wound	6.2% 1/16 • Up to Day 11
Vascular disorders Thrombophlebitis	6.2% 1/16 • Up to Day 11
Gastrointestinal disorders Diarrhoea	12.5% 2/16 • Up to Day 11
Gastrointestinal disorders Gastrooesophageal reflux disease	6.2% 1/16 • Up to Day 11
Gastrointestinal disorders Nausea	6.2% 1/16 • Up to Day 11
Gastrointestinal disorders Vomiting	6.2% 1/16 • Up to Day 11

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
Publication restrictions are in place

Restriction type: OTHER