Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation

NCT00829933 | Completed Phase 2 Results DMC

• 1 other identifier: DU176b-C-J225
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Factor Xa inhibition

Outcome Measures

Primary Outcomes (1)

• Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.

  The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.

  12 weeks

Secondary Outcomes (5)

• Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.

  12 weeks

• Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment

  12 weeks

• Pharmacodynamic Parameters (PT, PT-INR, and APTT)

  12 weeks

• Plasma DU-176 Concentration

  12 weeks

• Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )

  12 weeks

Study Arms (4)

1

EXPERIMENTAL

DU-176b low dose

Drug: DU-176b tablets

2

EXPERIMENTAL

DU-176b intermediate dose

Drug: DU-176b tablets

3

EXPERIMENTAL

DU-176b high dose

Drug: DU-176b tablets

4

ACTIVE COMPARATOR

Warfarin

Drug: Warfarin potassium tablets

Interventions

DU-176b tablets DRUG

DU-176b tablets taken once daily for up to 12 weeks

1; 2; 3

Warfarin potassium tablets DRUG

Warfarin potassium tablets taken once daily for up to 12 weeks

4

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-valvular atrial fibrillation who meet all of the following requirements will be considered for admission to the study:
• Age≧20years
• Atrial fibrillation confirmed by at least 2 electrocardiographic(ECG) tracings taken at an interval of ≧1week during the year before enrollment
• Presence of any (at least )one of the following risk factors for embolism:
• Hypertension
• Diabetes mellitus
• Congestive heart failure
• Previous transient ischemic attack (TIA) or cerebral infarction (more than 30 days before giving informed consent )
• Age≧75 years
• At time of giving informed consent.
• To be confirmed on ECG charts, etc.

You may not qualify if:

• Presence of any of the following conditions with increased risk of hemorrhage:
• History of intracranial, intraocular (excluding bleeding beneath the bulbar conjunctiva ), intrathecal, retroperitoneal, or non-traumatic intraarticular hemorrhage
• History of gastrointestinal hemorrhage during the year before giving informed consent
• History of peptic ulcers during the 90 days before giving informed consent
• Surgical treatment or trauma requiring hospitalization during the 30 days before giving informed consent
• Hemoglobin level \<10 g/dL platelet count \<10 ×10000 /μL at screening examinations
• Active hemorrhage\* present at giving informed consent or at enrollment
• Any invasive therapeutic or diagnostic procedure (e.g., surgery, tissue, biopsy, and tooth extraction) scheduled during the period from the time of informed consent until completion of the trial treatment.
• Any congenital hemorrhagic disease
• History of cerebral infarction or TIA within 30 days before giving informed consent
• Current treatment with any anticoagulant(other than warfarin)
• Concurrent rheumatic valvular disease
• History of valvular surgery
• Concurrent infectious endocarditis
• Concurrent cardiac myxoma

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: So Yoshino, Manager
• Organization: Daiichi Sankyo.,LTD

yoshino.so.ej@daiichisankyo.co.jp

81-90-8024-0742

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: March 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 25, 2019
• Results First Posted: January 26, 2015

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (1)