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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00686803 | Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension | PHASE2 | COMPLETED | 21 | — | — | Apr 1, 2008 | Jul 1, 2008 | Jul 19, 2013 | - | — |
The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach. •Maximum concentration (Cmax) The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.
Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible.
| Arm | Type | Description |
|---|---|---|
| PL3994 Dose A | EXPERIMENTAL | PL3994 Dose A |
| PL3994 Dose B | EXPERIMENTAL | PL3994 Dose B |
| PL3994 Dose C | EXPERIMENTAL | PL3994 Dose C |
| PL3994 Dose D | EXPERIMENTAL | PL3994 Dose D |
| PL3994 Dose E | EXPERIMENTAL | PL3994 Dose E |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| PL3994 | DRUG | Study drug |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history * Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history. * Subject must h...