A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Open Label, Randomised Exploratory Dose Response Study in Pharmacodynamics and Safety of BIBR 1048 (110 mg Twice Daily (b.i.d.) and 150 mg b.i.d.) for 12 Weeks in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

ClinicalTrials.gov ID

NCT01136408

Acronym / sponsor ID

1160.49

Conditions

Atrial Fibrillation

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

174 participants (actual)

Lead sponsor

Boehringer IngelheimIndustry (pharma, biotech, devices)

Study start

Nov 2005

Primary completion

Sep 2006 (actual)

First posted

3 Jun 2010 (estimated)

Results

Posted 17 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

3

Who may qualify

Ages

20 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Frequency (Occurrence Rates) of Major Bleeding Event

   Time frame: upto 15 weeks

   The percentage of patients with major bleeding event. Major bleeding was defined as any bleed fulfilling one of the following conditions: * Fatal or life-threatening * Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing) * Bleeding requiring surgical treatment * Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more * Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL

2. Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event

   Time frame: upto 15 weeks

   The percentage of patients with clinically relevant bleeding event. Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event: * A skin haematoma of at least 25 sqcm * Spontaneous nose bleed lasting for more than 5 minutes * Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours) * Spontaneous rectal bleeding (more than spotting on toilet paper) * Gingival bleeding lasting for more than 5 minutes * Bleeding leading to hospitalisation * Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US) * Any other bleeding considered clinically relevant by the investigator

3. Frequency (Occurrence Rates) of Nuisance Bleeding Event

   Time frame: Upto 15 weeks

   The percentage of patients with nuisance bleeding event Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event: * A skin haematoma of at least 25 sqcm * Spontaneous nose bleed lasting for more than 5 minutes * Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours) * Spontaneous rectal bleeding (more than spotting on toilet paper) * Gingival bleeding lasting for more than 5 minutes * Bleeding leading to hospitalisation * Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US) * Any other bleeding considered clinically relevant by the investigator

4. Incidence and Severity of Adverse Events

   Time frame: Upto 15 weeks

   Intensity of event is categorised as mild, moderate and severe.

5. Discontinuation of the Study Drug Due to Adverse Events

   Time frame: Upto 15 weeks

   Discontinuation of the study drug due to adverse events.

6. Changes in Laboratory Test Values

   Time frame: 12 weeks

   The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

28 sites in 1 country: see every site and its status.