NCT02222480已完成2 期
A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination With Hydrochlorothiazide in Patients With Mild to Moderate Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM)
研究概览
简要总结
A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects of no childbearing potential 19-70 years of age
- •Mean clinic-measured sitting DBP (siDBP) of 90-109 mmHg and mean clinic-measured sitting SBP (siSBP) of 140-179 mmHg after a ≥1-week washout of prior antihypertensive medications (no wash-out is needed for those not on any antihypertensive medications) with a difference of ≤10 mmHg in sitting DBP between before and after run-in
- •Subjects who agree to participate in this study and give written informed consent
- •Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
排除标准
- •Severe hypertension, i.e., mean siDBP ≥110 mmHg or mean siSBP ≥180 mmHg
- •Orthostatic hypotension with clinically significant signs or symptoms
- •Secondary hypertension
- •Not able to stop administration other antihypertensive medications than the study drugs (i.e., fimasartan and hydrochlorothiazide) throughout the entire study period
- •Clinically significant abnormal laboratory test results, e.g., serum creatinine >1.5 times upper limit of normal, AST, ALT > 2 times upper limit of normal
- •Conditions that may affect to absorption, distribution, metabolism, and excretion for the study drugs
- •Severe insulin-dependent or uncontrolled diabetes mellitus (HbA1c >9%, increased dose of an oral hypoglycemic agent within 12 weeks before screening, or active insulin treatment at screening)
- •Severe cardiovascular diseases within 6 months of screening including ischemic heart disease, peripheral vascular disease, significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia, hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease, severe cerebrovascular disease
- •History of percutaneous transluminal coronary angiography or coronary artery bypass graft
- •Chronic debilitating disease, autoimmune disease, connective tissue disease
- •Positive on serum hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-HIV antibody
- •History or evidence of alcohol or drug abuse within 2 years
- •Known allergic reaction to any angiotensin receptor blockers
- •Chronic inflammation disease requiring chronic anti-inflammation therapy
- •Women of childbearing potential without any contraceptive measure or breast-feeding mother
- •Prior participation in a clinical trial of any investigational products within 12 weeks from screening
- •Serum potassium <3.5 mmol/L or >5.5 mmol/L at any time of the study period
- •Depletion of sodium ion or body fluid, which cannot be corrected easily during the study period
- •Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Considered unsuitable to participate in the study under the discretion of the principal investigator
研究组 & 干预措施
Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg
Experimental
Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg
干预措施: Fimasartan (Drug)
Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg
Experimental
Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg
干预措施: Hydrochlorothiazide (Drug)
Fimasartan 60 mg, Hydrochlorothiazide 25 mg
Experimental
Combination of Fimasartan/Hydrochlorothiazide 60/25mg
干预措施: Fimasartan (Drug)
Fimasartan 60 mg, Hydrochlorothiazide 25 mg
Experimental
Combination of Fimasartan/Hydrochlorothiazide 60/25mg
干预措施: Hydrochlorothiazide (Drug)
Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg
Experimental
Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg
干预措施: Fimasartan (Drug)
Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg
Experimental
Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg
干预措施: Hydrochlorothiazide (Drug)
Fimasartan 120 mg, Hydrochlorothiazide 25 mg
Experimental
Combination of Fimasartan/Hydrochlorothiazide 120/25mg
干预措施: Fimasartan (Drug)
Fimasartan 120 mg, Hydrochlorothiazide 25 mg
Experimental
Combination of Fimasartan/Hydrochlorothiazide 120/25mg
干预措施: Hydrochlorothiazide (Drug)
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM)
时间窗: from baseline to 2 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy SubjectsJoint PainNCT05212259Vedic Lifesciences Pvt. Ltd.375
Unknown
2 期
Efficacy and Tolerability of Erenumab in Patients With Trigeminal NeuralgiaTrigeminal NeuralgiaNCT04054024Danish Headache Center80
已完成
2 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced ConstipationOpioid Induced ConstipationNCT01459926Glycyx Therapeutics217
终止
2 期
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)Primary Biliary Cirrhosis (PBC)NCT02609048Gilead Sciences41
已完成
2 期
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)Palmoplantar PustulosisNCT03988335Aristea Therapeutics, Inc.35