NCT00137293

Brief Summary

The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

December 10, 2007

Status Verified

December 1, 2007

First QC Date

August 25, 2005

Last Update Submit

December 6, 2007

Conditions

Arrhythmia

Keywords

Arrhythmia, syncope, antiarrhythmic

Outcome Measures

Primary Outcomes (1)

  • This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.

Secondary Outcomes (1)

  • This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article.

Interventions

GAP-486 (ZP-123)DRUG
0.9% Sodium Chloride, USPDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing an electrophysiology study for evaluation of heart rhythm.

You may not qualify if:

  • Patients with uncontrolled blood pressure
  • Patients with certain cardiac risk factors
  • Patients with significant kidney or liver problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

San Francisco, California, 94143, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20010, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Ottawa, Ontario, K1Y 4W7, Canada

Location

Unknown Facility

Toronto, Ontario, M5B 1W8, Canada

Location

Unknown Facility

Montreal, Quebec, H1T 1CB, Canada

Location

Unknown Facility

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Arrhythmias, CardiacSyncope

Interventions

rotigaptideSodium Chloride

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

November 1, 2005

Study Completion

October 1, 2006

Last Updated

December 10, 2007

Record last verified: 2007-12

Locations

CA(4)US(3)