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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02322450 | Phase IIa Study of the Product QGC001 Compared With Placebo in Patients With Essential Hypertension | PHASE2 | COMPLETED | 34 | — | — | Jan 1, 2015 | Apr 1, 2016 | Sep 28, 2016 | 4 | France |
Measurements will include mean 24h systolic and diastolic pressures, and daytime values (measured every 15 min from 07:00 am to 10:00 pm) and night-time values (measured every 20 min from 10:00 pm to 07:00 am). Only ambulatory BP recordings with a minimum of 24 measurements will be considered as successful.
| Arm | Type | Description |
|---|---|---|
| A: P1-QGC001 - Washout-placebo - P2-placebo | EXPERIMENTAL | The first period (P1) will correspond either to QGC001 or placebo, the second period (P2) will correspond either to QGC001 or placebo. |
| B: P1-placebo - Washout-placebo - P2-QGC001 | EXPERIMENTAL | The first period (P1) will correspond either to QGC001 or placebo, the second period (P2) will correspond either to QGC001 or placebo. |
| Name | Type | Description |
|---|---|---|
| QGC001 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male and female of non-childbearing potential patients (post-menopausal since at least 12 months or surgically sterilized) aged 18 to 75 years; * Body weight ≥50 kg with a body mass index (BMI) calculated as weight in kg/(height in m2) from 18 to 40 kg/m2 at screening; * A sig...