A Phase II Optimization Study of BMS068645 and Sestamibi... | NCT00162071

Studies
A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging

NCT00162071

Sponsor

Forest Laboratories

Status

Terminated

Last Update Posted

Feb 1, 2017Estimated

Enrollment

Phase

Phase 2

Conditions

Cardiovascular Disease
Ischemic Heart Disease

Interventions

apadenoson

Countries

United States

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decided not to continue with the development program

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 13, 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

Jan 31, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Description Module

Brief Summary

The primary purpose of this study is to determine the optimal time for myocardial perfusion imaging with Technetium Tc99m Sestamibi following the administration of BMS068645. The safety of BMS068645 will also be studied.

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

Name	Type	Description	Arm Group Labels	Other Names
apadenoson	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurements of Technetium Tc99m Sestamibi activity will be obtained from various regions of the body at the end of the study to determine optimal imaging times.

Secondary Outcomes

Measure	Description	Time Frame
A comparison of adverse events will be conducted at the end of the study to assess safety.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Have known or suspected heart disease
Have undergone a clinically indicated SPECT MPI study with adenosine in the last 24 hours to 14 days.
Weigh between 88 and 250 lbs.

Exclusion Criteria:

Allergic reaction to Technetium Tc99m Sestamibi or any of its components
History of asthma or lung disease
Ingestion of caffeinated substances within 12 hours prior to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
E Gordon DePuey, MD	St. Luke's-Roosevelt Hospital Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		New York	New York	10025	United States

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided