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The objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | TA-1790 + glyceryl trinitrate |
|
| Treatment B | Active Comparator | sildenafil citrate + glyceryl trinitrate |
|
| Treatment C | Placebo Comparator | placebo + glyceryl trinitrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-1790 | Drug | 2 TA-1790 100 mg capsules |
| |
| Sildenafil citrate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemodynamic measurements | Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements. | Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Peterson, MS | VIVUS LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services | Phoenix | Arizona | United States |
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| Drug |
2 sildenafil citrate 50 mg capsules |
|
| Placebo | Drug | 2 placebo capsules for TA-1790 100 mg capsules |
|
| Nitrostat | Drug | glyceryl trinitrate tablet, USP 0.4 mg |
|
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009574 | Nitro Compounds |
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