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Follow on Study From RE-ALIGN

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01505881
First received: January 5, 2012
Last updated: February 4, 2013
Last verified: January 2013
History of Changes
  Purpose

To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.


Condition Intervention Phase
Thromboembolism
Heart Valve Prosthesis
 Drug: dabigatran etexilate low dose
Drug: warfarin 5mg
Drug: dabigatran etexilate intermediate dose
Drug: warfarin 1mg
Drug: dabigatran etexilate high dose
Drug: warfarin 3mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 159
Study Start Date: December 2011
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran etexilate
Patient dose determined by dose allocated in 1160.113 and CrCl levels
 Drug: dabigatran etexilate low dose
active treatment (low)
Drug: dabigatran etexilate intermediate dose
active treatment (medium)
Drug: dabigatran etexilate high dose
active treatment (high)
Active Comparator: warfarin
warfarin doses to maintain INR levels
 Drug: warfarin 5mg
comparator warfarin
Drug: warfarin 1mg
comparator warfarin
Drug: warfarin 3mg
comparator warfarin

Detailed Description:

Based on an interim analysis from the phase II, 1160.113 and 1160.138 trials which suggested that the investigated dosing regimen did not achieve the desired results in this patient population, it was decided that from this point forward, patients will discontinue study medication and be followed up for a further six months.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Completed study 1160.113 per protocol
  2. Continuing need for anticoagulation

Exclusion criteria:

  1. uncontrolled hypertension
  2. severe renal impairment
  3. active liver disease
  4. increased risk of bleeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505881

  Show 41 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01505881     History of Changes
Other Study ID Numbers: 1160.138, 2011-002285-21
Study First Received: January 5, 2012
Last Updated: February 4, 2013
Health Authority: Belgium:
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
United States: Food and Drug Administration

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
 Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013