臨床研究等提出・公開システム

Date of registration	July. 26, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222155

Scientific Title	Phase III clinical study of DQ-2466 -Double-blind controlled study of fixed-dose and up-titration DQ-2466 regimens in subjects with persistent or permanent atrial fibrillation -
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co., Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		120
Study Type		Interventional
Study Design	Study Design	randomized, double-blind, 3-armed comparative study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who are diagnosed as persistent or permanent atrial fibrillation and have excessive mean heart rate above 80 beats per minute on Holter ECG.
	Exclusion Criteria	.Patients who recently took a beta-blocker or a calcium antagonist (e.g., diltiazem or verapamil) .Patients receiving treatment for heart failure (NYHA classes II to IV). .Patients with contraindication of carvedilol therapy. .Patients with poorly controlled diabetes mellitus or hypertension. .Patients with hepatic or renal impairment.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Persistent or permanent atrial fibrillation
Intervention(s)		investigational material(s) Generic name etc : DQ-2466 INN of investigational material : Carvedilol Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational material : The treatment period will be set at 6 weeks in each groups. 5 mg Fixed-dose group:DQ-2466 will be administered orally at a dose of 5 mg once daily 10mg-titration group:DQ-2466 will be administered orally at a dose of 5 mg or 10 mg once daily 20mg-titration group:DQ-2466 will be administered orally at a dose of 5 mg, 10 mg or 20mg once daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy endpoints (24-hour mean heart rate measured by Holter ECG) Safety endpoints (adverse events, laboratory tests, blood pressure, 12-lead ECG findings).
Secondary Outcome		The change of heart rate on the 12-lead ECG.

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-132201
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	July. 15, 2016	Detail	Changes
9	July. 15, 2016	Detail	Changes
8	April. 17, 2015	Detail	Changes
7	April. 17, 2015	Detail	Changes
6	Mar. 27, 2014	Detail	Changes
5	Mar. 27, 2014	Detail	Changes
4	Sept. 17, 2013	Detail	Changes
3	Sept. 17, 2013	Detail	Changes
2	July. 26, 2013	Detail	Changes
1	July. 26, 2013	Detail

List of change history