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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Darifenacin |
|
| 2 | Active Comparator | Tolterodine |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darifenacin | Drug | Darifenacin tablets 15 mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7 Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7 | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Phoenix | Arizona | United States | |||
| Investigative Site |
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| Tolterodine | Drug | Tolterodine extended release (ER) 4 mg once daily |
|
|
| Placebo | Drug | Placebo tablet once daily |
|
| Tempe |
| Arizona |
| United States |
| Investigative Site | Little Rock | Arkansas | United States |
| Investigative Site | San Diego | California | United States |
| Investigative Site | Washington D.C. | District of Columbia | United States |
| Investigative Site | Fort Myers | Florida | United States |
| Investigative Site | Jacksonville | Florida | United States |
| Investigative Site | Jupiter | Florida | United States |
| Investigative Site | Miami | Florida | United States |
| Investigative Site | Orlando | Florida | United States |
| Investigative Site | Overland Park | Kansas | United States |
| Investigative Site | Topeka | Kansas | United States |
| Investigative Site | Riverdale | Maryland | United States |
| Investigative Site | Wellesley Hills | Massachusetts | United States |
| Investigative Site | Springfield | Missouri | United States |
| Investigative Site | Hackensack | New Jersey | United States |
| Investigative Site | Burlington | North Carolina | United States |
| Investigative Site | Greensboro | North Carolina | United States |
| Investigative Site | Oklahoma City | Oklahoma | United States |
| Investigative Site | Knoxville | Tennessee | United States |
| Investigative Site | Morgantown | West Virginia | United States |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C101207 | darifenacin |
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
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