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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00943852 | The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317) | PHASE1 | COMPLETED | 13 | — | — | Aug 1, 2006 | Dec 1, 2006 | Feb 9, 2022 | - | — |
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | losartan 100 mg |
| 2 | ACTIVE_COMPARATOR | ISMN 60 mg |
| 3 | ACTIVE_COMPARATOR | losartan 100 mg + ISMN 15 mg |
| 4 | ACTIVE_COMPARATOR | losartan 100 mg + ISMN 60 mg |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| losartan potassium | DRUG | Single dose losartan 100 mg in one of five treatment periods |
| Comparator: isosorbide mononitrate (ISMN) | DRUG | Single dose ISMN 60 mg in one of five treatment periods |
| Comparator: losartan + ISMN | DRUG | Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods |
| Comparator: Placebo | DRUG | Single dose placebo only in one of five treatment periods |
Inclusion Criteria: * Patient is in good health with the exception of mild to moderate hypertension * Patient is willing to comply with the study restrictions * Patient does not smoke Exclusion Criteria: * Patient has a history of any illness that might confound the results of the study or make p...