Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery (NCT NCT00967447)

NCT ID: NCT00967447

Last Updated: 2025-02-11

Results Overview

Recruitment status

TERMINATED

Target enrollment

2 participants

Primary outcome timeframe

6 Months

Results posted on

2025-02-11

Participant Flow

Only two patients were included into the study. The sponsor decided to finish it due to a delay of recruitment period.

Participant milestones

Participant milestones
Measure
Dabigatran Exilate 220 Once Daily (OD)
10 days for Knee Replacement or 28-35 Hip Replacement
Overall Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 6 Months

Population: The trial was stopped due poor enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From 12 To 37 Days

Population: The trial was stopped due poor enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From 12 To 37 Days

Population: The trial was stopped due poor enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From 12 To 37 Days

Population: The trial was stopped due poor enrollment

Outcome measures

Outcome data not reported

Adverse Events

Dabigatran Exilate 220 Once Daily (OD)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Results disclosure agreements

  • Principal investigator is a sponsor employee Any publication of the results of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
  • Publication restrictions are in place

Restriction type: OTHER