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

NCT02322450 | Completed Phase 2

• 1 other identifier: QGC001/2QG1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Efficacy - 24h ABPM

  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.

  Change from Period 1 to Period 2 up to 16 weeks (end-of-study visit).

Secondary Outcomes (12)

• Efficacy - Self BP measurements at home

  Change from Period 1 to Period 2 up to 16 weeks.

• Efficacy - Office BP measurements

  Change from Period 1 to Period 2 up to 16 weeks.

• Efficacy - Hormonal measurements

  Change from Period 1 to Period 2 up to 16 weeks.

• Pharmacokinetics - Plasma levels of QGC001

  Change from Period 1 to Period 2 up to 16 weeks.

• Pharmacokinetics - Plasma levels of EC33

  Change from Period 1 to Period 2 up to 16 weeks.

Study Arms (2)

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.

Drug: QGC001; Drug: 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.

Drug: QGC001; Drug: Placebo

Interventions

QGC001 DRUG

A: P1-QGC001 - Washout-placebo - P2-placebo; B: P1-placebo - Washout-placebo - P2-QGC001

Placebo DRUG

A: P1-QGC001 - Washout-placebo - P2-placebo; B: P1-placebo - Washout-placebo - P2-QGC001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 signed and dated informed consent form before any study-specific screening procedure is performed;
• With a diagnosis of essential grade I or II hypertension defined as:
• a supine office systolic BP (SBP) of 140-159 mmHg or diastolic BP (DBP) of 90-99 mmHg who should have an additional clinical indication according to ESH guidelines for antihypertensive treatment after a 2-week placebo run-in period,
• or a supine office SBP of 160-179 mmHg or DBP of 100-109 mmHg after a 2-week placebo run-in period with a diagnosis of essential grade II hypertension;
• Diagnosis of permanent hypertension confirmed by a mean SBP or DBP higher than135 or 85 mmHg on daytime ambulatory blood pressure monitoring (ABPM) after a 2-week placebo run-in period;
• Estimated glomerular filtration rate (Modification of Diet in Renal Disease (MDRD) formula) ≥ 60 ml/min/1.73 m2.

You may not qualify if:

• Any significant hepatic, renal, respiratory (e.g., asthma), gastrointestinal, endocrine (e.g., diabetes, dyslipidemia necessitating drug therapy), immunologic, dermatological, hematological, neurologic, psychiatric disease or history of any clinically important drug allergy;
• Acute disease state (e.g., vomiting, fever, diarrhea) within 7 days before study day 1;
• Any history of transient ischemic accident (TIA) or cerebrovascular accident (CVA);
• Any history of acute heart failure or heart failure;
• Any history of myocardial infarction, unstable angina, coronary bypass or percutaneous coronary angioplasty;
• History of malignant tumor during the past 5 years;
• Any medical or surgical disorder considered by the investigator as increasing the risks of participation in the study, or liable to prevent the patient from complying with the requirements of the study or from continuing the study to completion;
• Any situation which, in the investigator's opinion, might compromise assessment of efficacy or of safety;
• History of non-adherence to treatment;
• History of drug abuse within 1 year before study day 1;
• History of alcoholism within 1 year before day 1;
• Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies;
• Use of any investigational drug within 30 days before IMP administration;
• Donation of blood (i.e., 500 ml) within 90 days before study day 1;
• Known secondary hypertension;

Sponsors & Collaborators

• Quantum Genomics SA: lead

Study Sites (4)

Hôpital Arthur Gardiner

Dinard, 35800, France

Location

Hôpital Cardiologique, CHRU de Lille

Lille, 59037, France

Location

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (2)

• Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.

  PMID: 33027067 DERIVED

• Azizi M, Courand PY, Denolle T, Delsart P, Zhygalina V, Amar L, Lantelme P, Mounier-Vehier C, De Mota N, Balavoine F, Llorens-Cortes C. A pilot double-blind randomized placebo-controlled crossover pharmacodynamic study of the centrally active aminopeptidase A inhibitor, firibastat, in hypertension. J Hypertens. 2019 Aug;37(8):1722-1728. doi: 10.1097/HJH.0000000000002092.

  PMID: 30882604 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

FR (4)