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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAP-486 (ZP-123) | Drug | |||
| 0.9% Sodium Chloride, USP | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento | California | 95819 | United States | |||
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| San Francisco |
| California |
| 94143 |
| United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Orlando | Florida | 32803 | United States |
| Peoria | Illinois | 61606 | United States |
| Iowa City | Iowa | 52242 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Lansing | Michigan | 48910 | United States |
| Southfield | Michigan | 48075 | United States |
| Minneapolis | Minnesota | 55407 | United States |
| Newark | New Jersey | 07112 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Cleveland | Ohio | 44109 | United States |
| Cleveland | Ohio | 44195 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Wynnewood | Pennsylvania | 19096 | United States |
| Falls Church | Virginia | 22042 | United States |
| Norfolk | Virginia | 23507 | United States |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Victoria | British Columbia | V8R 1H8 | Canada |
| St-Johnâ S | Newfoundland and Labrador | A1B 3V6 | Canada |
| Halifax | Nova Scotia | B3H 3A7 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Newmarket | Ontario | L3Y 8C3 | Canada |
| Toronto | Ontario | M5B 1WB | Canada |
| Fleurimont | Quebec | J1H 5N4 | Canada |
| Montreal | Quebec | H1T 1CB | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Montreal | Quebec | H4J 1C5 | Canada |
| Sainte-Foy | Quebec | G1V 4G5 | Canada |
| Sherbrooke | Quebec | J1H 5N4 | Canada |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C477643 | rotigaptide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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