EUCTR2004-000020-32-BE进行中（未招募）不适用
The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First LineTreatment for Severe Hypertension
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 826
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
- •* Subjects must have uncontrolled hypertension defined as:
- •currently untreated with an SeDBP = 110mmHg
- •currently receiving antihypertensive monotherapy with an SeDBP = 100mmHg.
- •Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy.
- •* Subjects must be willing to discontinue their antihypertensive medication, if
- •applicable.
- •To qualify for randomization to double-blind therapy:
- •- all evaluations including laboratory testing from the Enrollment Visit must be
- •completed and the results must satisfy all selection criteria,
- •- blood pressure measurement of an averaged SeDBP = 110mmHg must be
- •demonstrated at two consecutive visits (A01 and A99) off of medication and immediately prior to randomization (see Section 7.3.4 for BP standardization).
- •* Men and women, ages 18 and older will be included.
- •* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
- •25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study
- •medication.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* SeSBP = 220mmHg or SeDBP = 130mmHg and/or evidence of malignant or
- •accelerated hypertension or clinical evidence that the subject requires immediate
- •lowering of his/her blood pressure within hours, including, but not limited to coronary
- •ischemia or neurological signs and symptoms.
- •* Known or suspected secondary hypertension.
- •* Hypertensive encephalopathy, stroke, or transient ischemic attack within the past 12 months
- •* Myocardial infarction, percutaneous transluminal coronary revascularization,
- •coronary artery bypass graft, or unstable angina pectoris within the past six months
- •* New York Heart Association functional class III-IV congestive heart failure, or LV
- •dysfunction requiring ACE inhibitor
- •* Hemodynamically significant cardiac valvular disease
- •* Heart block greater than first degree atrioventricular block, preexcitation syndrome,
- •sick sinus syndrome, chronic atrial fibrillation, or chronic atrial flutter, or other
- •significant arrhythmias that may interfere with the blood pressure measurements
- •* Significant chronic renal impairment, or renovascular disease
- •* Significant liver disease
- •* Systemic lupus erythematosus
- •* Obesity that would limit accurate blood pressure measurement
- •* Positive pregnancy test
- •* Serum creatinine > 1.5 mg/dL
- •* AST, ALT, or total bilirubin > 3 times the upper limit of normal
- •* Plasma glucose > 240 mg/dL (if high, may be repeated once)
- •* Hemoglobin A1c > 10%
- •* Serum potassium < 3.3 or > 5.5 mmol/l
- •* White blood cell count < 2,600/µl
- •* Platelet count < 100,000/µl
- •* Hb < 10g/dL
研究者
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