Controlled Study of ONO-1101 in Patients With Postoperati... | NCT00212680

Studies
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

NCT00212680

Sponsor

Ono Pharma USA Inc

Status

Completed

Last Update Posted

Oct 11, 2012Estimated

Enrollment

100

Phase

Phase 2

Conditions

Postoperative Supraventricular Tachyarrythmia

Interventions

ONO-1101

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

Oct 2012

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 1996

Primary Completion Date

Apr 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 21, 2005Estimated

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

Oct 10, 2012

Last Update Posted Date

Oct 11, 2012Estimated

Description Module

Brief Summary

The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy and safety in patients with postoperative supraventricular tachyarrhythmias.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
ONO-1101	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients achieving 20% reduction in heart rate at each dose

Secondary Outcomes

Measure	Description	Time Frame
Heart Rate, Blood pressure and 12-lead ECG

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-80 years old
Postoperative supraventricular tachyarrhythmias (sinus tachycardia, those with a heart rate of 120 beats/min or higher, and supraventricular arrhythmia, those with a heart rate of 100 beats/min or higher)
Within 7 days postoperatively
Other inclusion criteria as specified in the protocol

Exclusion Criteria:

Acute myocardial infarction (within 1 month after onset)
Severe heart failure (New York Heart Association functional class III or higher)
Atrioventricular block (grade II or higher),or sick sinus syndrome
Other exclusion criteria as specified in the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Project Leader, Development Planning	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C077049	landiolol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided