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Dabigatran Etexilate in Patients With Mechanical Heart Valves

NCT01452347 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2014-08-06

Study results available
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Summary

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

Conditions

  • Heart Valve Diseases

Interventions

DRUG

warfarin 1mg

comparator warfarin

DRUG

dabigatran etexilate intermediate dose

active treatment (medium)

DRUG

dabigatran etexilate low dose

active treatment (low)

DRUG

warfarin 5mg

comparator warfarin

DRUG

dabigatran etexilate high dose

active treatment (high)

DRUG

warfarin 3mg

comparator warfarin

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Netherlands
  • Norway
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452347 on ClinicalTrials.gov