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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00221845 | Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure in Pediatric Patients | PHASE3 | COMPLETED | 400 | — | — | Jan 1, 1998 | Jan 1, 2010 | Jan 12, 2010 | 33 | Czechia, France +10 |
| Arm | Type | Description |
|---|---|---|
| Conventional BP Control | ACTIVE_COMPARATOR | Targeted 24-hour mean arterial pressure will be the 50th-95th percentile for age. |
| Intensified BP Control | EXPERIMENTAL | Targeted 24-hour mean arterial pressure will be the 5th to 50th percentile for age. |
| Name | Type | Description |
|---|---|---|
| ACE Inhibition | DRUG | ACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects. |
| Intensified Blood Pressure Control | DRUG | Any antihypertensive drugs except ACE inhibitors and angiotensin receptor blockers will be allowed. |
| Add-on Angiotensin Receptor Blockade | DRUG | In patients who show persistent or breakthrough proteinuria at the end of the initial study period, telmisartan (50 mg/m²/day) will be added to the existing medication. |
Inclusion Criteria: * Age 3-18 years * Moderate state of renal failure (creatinine clearance 15 - 75 ml / min / 1.73 m²) * Mean arterial blood pressure (ABPM) \> 50.percentile and/or antihypertensive treatment * Written informed consent Exclusion Criteria: * Age \<3 years or \>18 years at start o...