EUCTR2019-004509-29-ES进行中（未招募）1 期
A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects - Firibastat in treatment-RESistant Hypertension (FRESH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 502
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able to understand, and willing to provide written informed consent and able to comply with the study procedures and restrictions.
- •2. Men and women =18 years of age at Screening
- •3. Diagnosis of primary HTN for at least 6 months prior to Screening and:
- •Currently treated with at least 2 antihypertensive classes of drug, including a diuretic, at the MTDs (ie, the subject can tolerate the dose and has had no intolerable AEs), with no change (drug, regimen, and
- •dose) for at least 6 weeks and with medication adherence >80% during the Run-in Period.
- •Have a systolic AOBP between 140 mmHg and 170 mmHg (inclusive) at Screening while on their current chronic antihypertensive treatments.
- •Have a successful ABPM measurement according to the criteria in Section 6.2.2.1, with a mean systolic daytime ABP >135 mmHg after the Run-in Period while on their current chronic antihypertensive treatments.
- •4. Women of childbearing potential and nonsurgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days postdose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- •Note: The following categories define women who are NOT considered to be of childbearing potential:
- •Premenopausal women with 1 of the following:
- •o Documented hysterectomy
- •o Documented bilateral salpingectomy
- •o Documented bilateral oophorectomy
- •Postmenopausal women, defined as having amenorrhea for at least 12 months without an alternative medical cause.
- •5. Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Visit 2, Day 1).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 402
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
- •2. Automated office SBP >170 mmHg or DBP >110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
- •3. Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.
- •4. Upper arm circumference that is outside the limits of the study provided BP cuff associated with either the ABPM and/or AOBP measurement device.
- •5. History of spontaneous or drug-induced angioedema.
- •6. History of drug-related allergy or hypersensitivity to any components of the IP (firibastat [QGC001] or placebo).
- •7. Known severe aortic stenosis (symptomatic or asymptomatic with valvular indexed surface <0.5 cm²/m²).
- •8. Subjects with severe symptomatic HF (NYHA Class III or Class IV).
- •9. History of acute coronary syndrome (non-ST elevation MI, ST elevation MI, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to Screening.
- •10. Known history of malabsorption syndrome, or has undergone gastrointestinal surgery, including bariatric procedures, that induce chronic malabsorption, within 2 years of Screening.
- •11. Treatment with antiobesity drugs or procedures 3 months prior to Screening (ie, surgery, aggressive diet regimen, etc.), leading to unstable body weight.
- •12. Female who is breastfeeding, pregnant, or planning to become pregnant during the study period.
- •13. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 3 years.
- •14. Shift workers who routinely sleep during the daytime and/or whose work hours include midnight.
- •15. Subjects with moderate to severe hepatic impairment (Child-Pugh B or C); alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >3×upper limit of normal (ULN), or a total bilirubin =1.5×ULN (unless secondary to Gilbert's syndrome), or direct bilirubin >ULN in subjects with Gilbert's syndrome at Screening.
- •16. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)41 formula at Screening.
- •17. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (eg, malaria, babesiosis, hemolytic
- •18. Subjects with documented DI.
- •19. Subjects with Type 1 diabetes mellitus.
- •20. Subjects with Type 2 diabetes mellitus who:
- •Are poorly controlled, defined as glycosylated hemoglobin A1c (HbA1c) >9% at Screening; OR
- •Are taking short-acting insulin or sodium-glucose co-transporter 2 (SGLT2) inhibitors. Use of a stable dose(=12 weeks prior to Screening) of medications listed in Section 7.7.1 is permitted.
- •21. Routine or anticipated treatment with any systemic corticosteroid. Use of topical, inhaled, intra-articular, or nasal corticosteroids is permitted.
- •22. Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable =4 weeks prior to Screening, or a thyroid-stimulating hormone (TSH) level <0.75×lower limit of normal or >1.5×ULN at Screening.
- •23. History of alcohol or drug abuse (including opioid overuse/misuse) within the 3 months prior to Screening that would interfere with study participation or lead to decreased compliance to study procedures or IP
- •intake in the investigator's opinion.
- •24. Participation in another clinical study involving an investigational
研究者
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