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Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran

NCT ID: NCT01595854

Last Updated: 2013-08-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-06-30

Brief Summary

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Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test 2 (part 3)

low dose dabigatran + high dose ticagrelor

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

high dose ticagrelor

dabigatran etexilate

Intervention Type DRUG

medium dose dabigatran

Test 1 (part 1 + 2)

high dose ticagrelor

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

high dose ticagrelor

Reference 1 (part 1 + 2)

medium dose dabigatran

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

medium dose dabigatran

Reference 2 (part 3)

low dose dabigatran

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

low dose dabigatran

Interventions

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dabigatran etexilate

medium dose dabigatran

Intervention Type DRUG

Ticagrelor

high dose ticagrelor

Intervention Type DRUG

Ticagrelor

high dose ticagrelor

Intervention Type DRUG

dabigatran etexilate

low dose dabigatran

Intervention Type DRUG

dabigatran etexilate

medium dose dabigatran

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male subjects

Exclusion Criteria

2. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.141.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-000874-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.141

Identifier Type: -

Identifier Source: org_study_id