JPRN-jRCT2080222638未知3 期
A Phase III, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Long-term administration of TAK-536, Amlodipine (AML), and Hydrochlorothiazide (HCTZ) in Patients with Essential Hypertension
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 341 人开始时间: 2014年10月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 341
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
- •2.The participant signs and dates an informed consent form prior to the initiation of any study procedures.
- •3.The participant has essential hypertension.
- •4.The participant's clinic sitting systolic blood pressure (SBP) is < 180 mmHg and clinic sitting diastolic blood pressure (DBP) is < 110 mmHg at the start of the run-in period (Week -4). Patients receiving treatment with a three-drug antihypertensive within 4 weeks prior to the start of the run-in period must have a clinic sitting SBP of < 160 mmHg and clinic sitting DBP of < 100 mmHg.
- •5.The participant's clinic sitting blood pressure at Week -2 and the end of the run-in period (Week 0) is:
- •Sitting SBP is >= 140 mmHg or sitting DBP is >= 90 mmHg
- •Sitting SBP is >= 130 mmHg or sitting DBP is >= 80 mmHg
- •6.The participant's clinic sitting SBP is < 160 mmHg and clinic sitting DBP is < 100 mmHg at the end of the run-in period (Week 0).
- •7.Sex: male and/or female; Aged 20 years or older at the time when informed consent is obtained.
- •8.Hospitalization status: Outpatient
- •9.A female participant of childbearing potential who are sexually active with a nonsterilized male partner agree to use routinely adequate contraception from signing of informed consent to 1 month after the end of the study.
排除标准
- •1.The participant has received any investigational compounds within 12 weeks prior to the start of the run-in period.
- •2.The participant has participated in other clinical trials or post-marketing studies within 30 days prior to the start of the run-in period.
- •3.The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (e.g. spouse, parent, child, sibling), or may consent under duress.
- •4.The participant requires treatment with a prohibited concomitant drug during the study.
- •5.The participant has a history of hypersensitivity or allergies to TAK-536, AML, HCTZ, any thiazide diuretic or analog, any dihydropyridine drug, or any analog of TAK-536TCH.
- •6.The participant may, in the opinion of the investigator or subinvestigator, experience an excessive increase in blood pressure when changing or discontinuing premedication.
- •7.The participant previously received treatment with a three-ingredient antihypertensive drug with the same three ingredients found in TAK-536TCH.
- •8.The participant received therapy with 4 or more different antihypertensive agents within 4 weeks prior to the start of the run-in period.
- •9.The participant has secondary or malignant hypertension.
- •10.The participant's clinic sitting SBP at Week -4 differs between left and right arms by >= 20 mmHg.
- •11.The participant has apparent white coat hypertension or shows a white coat effect.
- •12.The participant leads a nocturnal lifestyle due to working a night shift or for another reason.
- •13.The participant has sleep apnea syndrome requiring treatment.
- •14.The participant has any of the following cardiovascular diseases:
- •- Cardiac disease: Myocardial infarction, coronary arterial revascularization, severe valvular disorder, atrial fibrillation, any of the following disorders when drug treatment is required: angina pectoris, congestive heart failure, arrhythmia
- •- Cerebrovascular disorders: Cerebral infarction/cerebral hemorrhage, transient ischemic attack
- •- Vascular disease: Peripheral artery disease with intermittent claudication, artery dissection, aneurysm
- •- Advanced hypertensive retinopathy: With bleeding or exudate/papilledema
- •15.The participant has a clinically apparent hepatic disorder (e.g., alanine aminotransferase (AST) or aspartate aminotransferase (ALT) at Week -2 of the run-in period >= 2.5 times the upper limit of normal).
- •16.The participant has a clinically severe renal disorder (e.g., eGFRcreat in laboratory tests performed at Week -2 of run-in period < 30 mL/minute/1.73 m2).
- •17.The participant's body fluid sodium or potassium level is markedly low or high.
- •18.The participant has gout or had gout within 24 weeks prior to the start of the run-in period or has hyperuricemia requiring drug treatment.
- •19.The participant has poorly controlled diabetes (e.g., HbA1c >= 7.4% in laboratory tests performed at Week -2 of run-in period).
- •20.The participant has a malignancy.
- •21.If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period..
- •22.The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the start of the run-in period.
- •23.The participant is otherwise found ineligible by the investigator or subinvestigator.
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