Study of DU-176b Aged 80 Years or Older

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: placebo; Drug: Du-176b

Study type: Interventional

Funder types: Industry

Identifiers

NCT02801669

163266 (Registry Identifier)

DU176b-C-J316

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.

Enrollment: 984 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy

Exclusion criteria

• Patients with active bleeding
• Patients who have poorly controlled hypertension
• Patients who have liver dysfunction accompanied with disorder of blood coagulation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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984 participants in 2 patient groups, including a placebo group

DU-176b 15 mg group

Experimental group

Description:

DU-176b orally administered at a dose of 15 mg once daily.

Treatment:

Drug: Du-176b

Placebo group

Placebo Comparator group

Description:

Placebo orally administered once daily.

Treatment:

Drug: placebo