Trial Outcomes & Findings for Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function (NCT NCT01896297)

Results Overview

Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

63 participants

Primary outcome timeframe

Immediately before the last drug administration, on day 8

Results posted on

2016-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Dabigatran Etexilate Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Overall Study STARTED	60
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dabigatran Etexilate Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Overall Study Died in post treatment phase	1

Baseline Characteristics

Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabigatran Etexilate n=60 Participants Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Age, Continuous	83.35 Years STANDARD_DEVIATION 7.55 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately before the last drug administration, on day 8

Population: Pharmacokinetic (PK) set (PKS) which included all patients in the treated set with analyzable data in at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK. Analysis includes patients with available data.

Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=51 Participants Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose	155 ng/mL Geometric Coefficient of Variation 76.9

PRIMARY outcome

Timeframe: 2 hours after the last drug administration, on day 8

Population: PKS. Analysis includes patients with available data.

Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate n=59 Participants Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose	202 ng/mL Geometric Coefficient of Variation 70.6

Adverse Events

Dabigatran Etexilate

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dabigatran Etexilate n=60 participants at risk Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
Cardiac disorders Acute myocardial infarction	1.7% 1/60 • From first drug administration until 3 days after last drug administration, up to 18 days
Metabolism and nutrition disorders Hyperkalaemia	1.7% 1/60 • From first drug administration until 3 days after last drug administration, up to 18 days

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

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