NCT02322450

Phase IIa Study of the Product QGC001 Compared With Placebo in Patients With Essential Hypertension

Multicenter, Randomized, Double-blind, Two-period, Placebo Controlled, Forced-titration Proof of Concept Crossover Study to Compare QGC001 With Placebo in Patients With Grade I or II Essential Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Quantum Genomics SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

2QG1 is a Phase IIa study aiming to assess the blood pressure lowering effect of 4-week administration of QGC001 oral doses in patients with grade I or II essential hypertension compared to placebo, to assess the safety and tolerability, to obtain preliminary PK information for QGC001 given as multiple oral doses and to determine preliminary PD profile of QGC001 multiple oral doses on plasma and urine hormones, which will be compared to that of placebo.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	QGC001
DRUG	Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-12-23
• Last updated: 2016-09-28

Locations

4 sites across 1 country: France