Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00137332 |
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Recruitment Status :
Terminated
First Posted : August 29, 2005
Last Update Posted : December 10, 2007
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
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Brief Summary:
The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Arrhythmia | Drug: GAP-486 (ZP-123) Drug: 0.9% Sodium Chloride, USP | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction |
| Study Start Date : | November 2005 |
| Actual Study Completion Date : | October 2006 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered.
Secondary Outcome Measures :
- This study takes place within 24 hours, and looks at whether the test article makes a difference in inducing the abnormally fast heart rhythm during a 24 hour observational period.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with or without ICDs (implantable cardioverter defibrillators)
- Patients undergoing an electrophysiology study for evaluation of ventricular rhythm
- Patients with a history of heart disease
Exclusion Criteria:
- Patients with uncontrolled blood pressure
- Patients with certain cardiac risk factors
- Patients with significant kidney or liver problems
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137332
Locations
| United States, California | |
| Sacramento, California, United States, 95819 | |
| San Francisco, California, United States, 94143 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Orlando, Florida, United States, 32803 | |
| United States, Illinois | |
| Peoria, Illinois, United States, 61606 | |
| United States, Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Massachusetts | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Lansing, Michigan, United States, 48910 | |
| Southfield, Michigan, United States, 48075 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New Jersey | |
| Newark, New Jersey, United States, 07112 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44109 | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States, 17033 | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, Virginia | |
| Falls Church, Virginia, United States, 22042 | |
| Norfolk, Virginia, United States, 23507 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Victoria, British Columbia, Canada, V8R 1H8 | |
| Canada, Newfoundland and Labrador | |
| St-Johnâ s, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| London, Ontario, Canada, N6A 5A5 | |
| Newmarket, Ontario, Canada, L3Y 8C3 | |
| Toronto, Ontario, Canada, M5B 1WB | |
| Canada, Quebec | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Montreal, Quebec, Canada, H1T 1CB | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Sainte-Foy, Quebec, Canada, G1V 4G5 | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00137332 |
| Other Study ID Numbers: |
3163K1-202 |
| First Posted: | August 29, 2005 Key Record Dates |
| Last Update Posted: | December 10, 2007 |
| Last Verified: | December 2007 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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Arrhythmia antiarrhythmic programmed electrical stimulation |
Additional relevant MeSH terms:
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Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |