Oral Carvedilol in Escalating Doses in the Acute Treatmen... | NCT02832089

Studies
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation

NCT02832089

Sponsor

Andhra Medical College

Status

Completed

Last Update Posted

Jul 14, 2016Estimated

Enrollment

30Actual

Phase

Phase 3

Conditions

Atrial Fibrillation

Interventions

oral carvedilol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2000

Primary Completion Date

Mar 2002Actual

Completion Date

Mar 2002Actual

First Submitted Date

Dec 28, 2015

First Submission Date that Met QC Criteria

Jul 11, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2016

Last Update Posted Date

Jul 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
active arm	Experimental	single arm study with one group given oral carvedilol.	Drug: oral carvedilol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral carvedilol	Drug	oral carvedilol in escalating doses for reducing ventricular rate in AF patients	active arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction in ventricular rate in AF patients	reduction in ventricular rate in patients with AF and fast ventricular rate.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AF with fast ventricular rate

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077261	Carvedilol

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided