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QGC001 · 2 trials · 2 indications
Office blood pressure will be taken at Day 0, Visit 3, Visit 4, Visit 4.1, and Visit 5 (Day 56).
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 |
|---|---|---|
| QGC001 | EXPERIMENTAL | Capsules of QGC001 250 mg |
| 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 | Twice daily (BID) administration of oral (PO) QGC001 (250 mg BID, 500 mg BID, and 500 mg BID + hydrochlorothiazide (HCTZ) 25 mg once daily \[QD\]) over 8 weeks. |
| Placebo | DRUG | - |
Inclusion Criteria: * Subject must provide signed written informed consent; * Men and women greater than or equal to 18 years of age at Screening; * Diagnosis of primary (essential) hypertension (HTN) for at least 3 months prior to Screening and have an office SBP: * Between 145 mmHg and 170 mmH...
QGC001 is an investigational small molecule being developed for the treatment of hypertension, including essential hypertension. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
QGC001 is being developed by Quantum Biopharma Ltd., a biopharmaceutical company traded on the stock exchange under the ticker symbol QNTM.
QGC001 is in Phase 2 clinical development. It has completed two Phase 2 trials, and it remains an investigational drug that has not received regulatory approval.
QGC001 has been studied in two completed Phase 2 trials: NCT02322450, a placebo-controlled study in patients with essential hypertension in France, and NCT03198793, a study in hypertensive overweight patients of multiple ethnic origins in the United States.
QGC001 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information.