Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
oral carvedilol
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, rate reduction
Eligibility Criteria
Inclusion Criteria:
- AF with fast ventricular rate
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
active arm
Arm Description
single arm study with one group given oral carvedilol.
Outcomes
Primary Outcome Measures
reduction in ventricular rate in AF patients
reduction in ventricular rate in patients with AF and fast ventricular rate.
Secondary Outcome Measures
Full Information
NCT ID
NCT02832089
First Posted
December 28, 2015
Last Updated
July 11, 2016
Sponsor
Andhra Medical College
1. Study Identification
Unique Protocol Identification Number
NCT02832089
Brief Title
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation
Official Title
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
March 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andhra Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Oral carvedilol administered in escalating doses in patients with atrial fibrillation among patients with AF with fast ventricular rate.
Detailed Description
Patients with AF with FVR of any etiology were evaluated and given escalating doses of oral carvedilol in doses - 3.125mg OD, then 3.125 bid, then 6.25mg bid, then 12.5mg bid. The ECG was recorded regularly and analysed for rate reduction or control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, rate reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active arm
Arm Type
Experimental
Arm Description
single arm study with one group given oral carvedilol.
Intervention Type
Drug
Intervention Name(s)
oral carvedilol
Other Intervention Name(s)
oral carvedilol in esclating doses
Intervention Description
oral carvedilol in escalating doses for reducing ventricular rate in AF patients
Primary Outcome Measure Information:
Title
reduction in ventricular rate in AF patients
Description
reduction in ventricular rate in patients with AF and fast ventricular rate.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AF with fast ventricular rate
Exclusion Criteria:
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation
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