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

Exclusion Criteria

• •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;
• •Grade III hypertension;
• •Estimated glomerular filtration rate (MDRD formula) below 60 ml/min/1.73 m2 ;
• •Type I diabetes mellitus or uncontrolled type II diabetes mellitus (HbA1C ≥ 8%);
• •Severe obesity (BMI ≥ 40 kg/m2);
• •Arm circumference ≥ 42 cm;
• •Atrial fibrillation;
• •Known hypersensitivity to drugs;
• •History of spontaneous or drug induced angioneurotic edema;
• •Use of any of the following medications within the four (4) weeks prior to dosing:
• •* Thyroid medication, statin therapy, oral antidiabetic drugs, estrogen replacement therapy and/or chronic low dose aspirin (75 mg/day) unless the patient has been on a stable maintenance dose for at least 3 months prior to screening.
• •* Anticoagulant treatments
• •* Cholestyramine resins.
• •* Treatment with oral, topical, inhaled, eye drop corticosteroids
• •* Treatment with class Ia, Ib and Ic or III anti-arrhythmics
• •* CNS drugs
• •* P-glycoprotein (P-gp) inhibitors (e.g., verapamil, quinidine, ritonavir),
• •* known cytochrome P450 inducers or inhibitors (eg, ketoconazole/CYP3A4, quinidine/CYP2D6, gemfibrozil/CYP2C8)
• •* Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase (COX)-2 inhibitors.
• •* Vasodilators or vascular muscle relaxants prescribed for other conditions
• •Unlikely to cooperate in the study and/or poor compliance anticipated by the investigator, e.g., uncooperative attitude, inability to return for follow-up visit, and unlikelihood of completing the study;
• •Participation in another interventional study at the same time or within 3 months prior to the beginning of the present study;
• •Participant not affiliated with the French social security;
• •No written informed consent;
• •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms);
• •A history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
• •The use of concomitant medications that prolong the QT/QTc interval.