Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01366664 | A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin | PHASE1 | COMPLETED | 24 | — | — | Apr 1, 2011 | Apr 1, 2012 | Oct 7, 2014 | 6 | United States |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Treatment sequence 1 Treatment Period 1 (stable dose of terazosin \[2 to 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2 to 10 mg\] + placebo administered orally once daily for 5 days) |
| 002 | EXPERIMENTAL | Treatment sequence 2 Treatment Period 1 (stable dose of terazosin \[2 to 10 mg\] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2 to 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) |
| Name | Type | Description |
|---|---|---|
| Treatment sequence 2 | DRUG | Treatment Period 1 (stable dose of terazosin \[2, 5, or 10 mg\] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2, 5, or 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) |
| Treatment sequence 1 | DRUG | Treatment Period 1 (stable dose of terazosin \[2, 5, or 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2, 5, or 10 mg\] + placebo administered orally once daily for 5 days) |
Inclusion Criteria: * On a stable regimen of terazosin (2 to 10 mg) or doxazosin (2 to 8 mg) taken daily for at least 6 weeks for the treatment of hypertension or benign prostatic hyperplasia * a body mass index between 18 and 35 kg/m², inclusive * a body weight of not less than 50 kg * supine (lay...