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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02678000 | Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function | PHASE2 | COMPLETED | 84 | — | — | Mar 10, 2017 | Oct 11, 2018 | Oct 6, 2021 | 12 | United States, Germany |
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. For LHW090, incidence of AEs by primary organ class presented
The area under the plasma concentration-time curve from time zero to 24 hours. Area Under the Curve (AUC0-t) after 4 days dosing will be reported for PART 1. LHW090 and LHV527 (its active metabolite)
Patients who developed a renal event will be reported (defined as a ≥0.3 mg/dL increase in serum creatinine from baseline within 24-48 hours post dose )
| Arm | Type | Description |
|---|---|---|
| LHW090 | EXPERIMENTAL | For Part 1, patients will receive 3 doses of LHW090 once daily with escalating doses every 4 days for a total 12 days of treatment. For Part 2, patients will receive LHW090 once daily for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | For Part 1, patients will receive matching placebo once daily for 12 days. For Part 2, patients will receive matching placebo once daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| LHW090 | DRUG | LHW090 is orally administered |
| Placebo | DRUG | Matching placebo of LHW090 |
Inclusion Criteria (all Parts): * Written informed consent must be obtained before any assessment is performed. * Male and female patients, age 40 to 85 years of age (inclusive) on a stable (at least 1 month) dose of an angiotensin receptor blocker (ARB) and stable moderately impaired renal functio...