NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Persistent or permanent atrial fibrillation
Date of first enrollment	26/07/2013
Target sample size	120
Countries of recruitment
Study type	Interventional
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

Outcome(s)

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.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.