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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
Andhra Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, rate reduction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 28, 2015
    Last Updated
    July 11, 2016
    Sponsor
    Andhra Medical College
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    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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