EUCTR2021-001404-14-SK进行中（未招募）1 期
A Phase 3, Double-blind, Placebo-controlled and Open-label Efficacy and Long-term Safety Study of Firibastat (QGC001) Administered Orally, Once Daily, for Up to 48 Weeks in Patients with Difficult-to-treat/Resistant Hypertension. - REFRESH
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
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. Adult men and women (at Screening). For all countries, age criteria
- •must be as per local regulations; eg, subjects in Canada must be aged =
- •18 years or =19 years of age at Screening, as per the applicable
- •Canadian provincial criteria.
- •3. Diagnosis of primary HTN for at least 6 months prior to Screening and:
- •Currently treated with 2 antihypertensive classes of drug (difficult-totreat subjects), or currently treated with at least 3 antihypertensive
- •classes of drug including a diuretic (treatment resistant subjects), at the
- •MTDs of those medications (ie, the subject can tolerate the current dose
- •of each medication but higher doses have caused or may worsen side
- •effects), with no change in their antihypertensive regimen (drug, dose,
- •or schedule) for at least 6 weeks, and with medication adherence =80%
- •during the Run in Period.
- •Have a systolic AOBP between 140 mmHg and 179 mmHg (inclusive) at
- •Screening (Visit 1) while on their current chronic antihypertensive
- •XML File Identifier: /cZS0tiMfTkErIENpoiq1NOT1v8=
- •treatments.
- •Have a successful ABPM measurement with a mean systolic daytime
- •ABP >135 mmHg after the Run-in Period while on their current chronic
- •antihypertensive treatments. An ABPM is successful if at least 21
- •daytime readings and 6 nighttime readings have been successfully
- •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 post-dose. Approved forms of contraception include intrauterine
- •devices, intrauterine hormone-releasing systems, bilateral tubal ligation,
- •or hormonal contraceptives (oral birth control pills, depo, patch, or
- •injectable) together with supplementary method such as condoms or
- •diaphragms with spermicidal gel or foam.
- •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 2B, 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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •1. Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing’s disease).
- •2. Systolic AOBP =180 mmHg or DBP =110 mmHg at the Screening or Inclusion Visit (Visit 2B, 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 any 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 heart failure (New York Heart Association [NYHA] Class III or Class IV).
- •9. History of acute coronary syndrome (non-ST elevation myocardial infarction [MI], ST elevation MI, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to Visit 2A, Day 0.
- •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 anti-obesity 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 A, 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) formula (Levey AS, et al. 2009) at Screening.
- •17. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (eg, malaria, babesiosis, hemolytic anemia, thalassemia, sickle cell anemia).
- •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. Use of a stable dose [=12 weeks prior to Screening] of the following medications, (or any combination of the following medications) is permitted: glucagon like peptide 1 analog, metformin, sulfonylurea, dipeptidyl peptidase-4 inhibitor, and single basal insulin, sodium glucose co-transporter 2 (SGLT2) inhibitors and pioglitazone.
- •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
研究者
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