Randomised trial to investigate possible differences in biological availability and effectiveness between vitamin K solution in oil and vitamin K tablets. - Compariso

• Conditions: owering anticoagulant effect of vitamin K antagonists in case of over-anticoagulation or pending diagnostic or therapeutic invase action.; MedDRA version: 12.1Level: LLTClassification code 10053755Term: Vitamin K antagonist; MedDRA version: 12.1Level: LLTClassification code 10058768Term: Vitamin K; MedDRA version: 12.1Level: LLTClassification code 10011970Term: Decreased INR; MedDRA version: 12.1Level: LLTClassification code 10037818Term: Raised INR

• Registration Number: EUCTR2010-022826-34-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Minimal 18 years of age.
- Step 1: healthy volunteer.
- Step 2: patient being treated with phenprocoumon undergoing an invasive diagnostic or therapeutic procedure for which reducing of the INR is necessary.
- Step 3: patient being treated with phenprocoumon having an INR between 7.0 and 10.0 for which reducing with vitamin K is necessary.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Being treated for liver failure.
- Pregancy, pregnancy wish or lactational period.
- Dialysis (both hemodialysis and peritoneal dialysis)
- Participation in the self management program.
- Inability to take care of own medication and / or proven non-compliance with treatment protocols.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified