Dabigatran Etexilate for Stroke Prevention in Patients Wi... | NCT01721837

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Atrial fibrillation and mild to moderate renal impairment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)	The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.	One single observation time point: at the time of prescription before the first intake of dabigatran etexilate

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site 626		Aachen			Germany
Boehringer Ingelheim Investigational Site 627

Results Section

Participant Flow Module

ID	Title	Description
FG000	All Patients	All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

For 5 patients the documentation of date of birth is missing, so age could be calculated for N=2115 patients.

Mean

Standard Deviation

years

Title

Denominators

Categories

Female

Title	Measurements
	BG0001015

Male

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)

The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.

All patients with documented mild or moderate renal impairment and non-valvular atrial fibrillation (PPS) having evaluable data for age, gender, body weight, and serum creatinine. In 145 patients age, gender, serum creatinine or weight was missing so that Creatinine Clearance according to the Cockcroft Gault formula could not be recalculated.

Posted

Median

Inter-Quartile Range

ml/min

One single observation time point: at the time of prescription before the first intake of dabigatran etexilate

ID	Title	Description
OG000	All Patients	All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).

Units	Counts
Participants	OG0001975

Title

Denominators

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms