Clinical trial NCT01773174: Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
Official title: Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group


Eligibility criteria: Inclusion criteria:

1. males or females 1 to less than 2 years of age
2. objective diagnosis of primary venous thromboembolism
3. completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism
4. written informed consent by parent (legal guardian) and patient assent (if applicable)

Exclusion criteria:

1. weight less than 9 kg
2. conditions associated with increased risk of bleeding
3. patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply

Primary outcomes:
measure: Ecarin clotting time (ECT)
timeFrame: one day
measure: Factor IIa inhibition
timeFrame: one day
measure: Incidence of all bleeding events
timeFrame: 30 days
measure: Incidence of all adverse events
timeFrame: 30 days
measure: Plasma concentrations of total dabigatran
timeFrame: one day
measure: Plasma concentrations of free dabigatran
timeFrame: one day
measure: Plasma concentrations of BIBR 1048 BS (Base)
timeFrame: one day
measure: Plasma concentrations of BIBR 951 BS
timeFrame: one day
measure: Plasma concentrations of BIBR 1087 SE (Acid)
timeFrame: one day
measure: Activated prothrombin time (aPTT)
timeFrame: one day
Secondary outcomes:
measure: Global assessment of tolerability will be summarized across all patients in the treated set
timeFrame: 30 days
measure: Patient assessment of taste will be summarized across all patients in the treated set
timeFrame: one day
measure: Changes in laboratory and clinical parameters
timeFrame: 30 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: 1160.145.00010 Boehringer Ingelheim Investigational Site
state: California
city: Louisville
country: United States
facility: 1160.145.00009 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Boston
country: United States
facility: 1160.145.00008 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: 1160.145.00012 Boehringer Ingelheim Investigational Site
state: Missouri
city: Newark
country: United States
facility: 1160.145.00007 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Pittsburgh
country: United States
facility: 1160.145.0006 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: 1160.145.00001 Boehringer Ingelheim Investigational Site
state: Texas
city: Spokane
country: United States
facility: 1160.145.00011 Boehringer Ingelheim Investigational Site
state: Washington
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: