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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01885559 | HALT Progression of Polycystic Kidney Disease Study B | PHASE3 | COMPLETED | 486 | — | — | Jan 1, 2006 | Jun 1, 2014 | Apr 22, 2020 | 7 | United States |
| Arm | Type | Description |
|---|---|---|
| ACE-I + placebo | PLACEBO_COMPARATOR | Monotherapy of lisinopril and placebo. Standard blood pressure control of 110-130/80 mm Hg |
| ACE-I + ARB | ACTIVE_COMPARATOR | Dual therapy of lisinopril and telmisartan treatments. Standard blood pressure control of 110-130/80 mm Hg. |
| Name | Type | Description |
|---|---|---|
| Lisinopril | DRUG | Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
| Telmisartan | DRUG | Telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
| Placebo | DRUG | Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. |
Inclusion Criteria: * Diagnosis of ADPKD. * Age 15-49 (Study A); Age 18-64 (Study B). * GFR \>60 mL/min/1.73 m2 (Study A); GFR 25-60 mL/min/1.73 m2 (Study B). * BP ≥130/80 or receiving treatment for hypertension. * Informed Consent. Exclusion Criteria: * Pregnant/intention to become pregnant in 4...