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
Phase 3
- Conditions
- Persistent or permanent atrial fibrillation
- Registration Number
- JPRN-jRCT2080222155
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy endpoints (24-hour mean heart rate measured by Holter ECG)<br>Safety endpoints (adverse events, laboratory tests, blood pressure, 12-lead ECG findings).
- Secondary Outcome Measures
Name Time Method The change of heart rate on the 12-lead ECG.