EUCTR2005-000614-12-ES进行中（未招募）1 期
Irbesartan in the treatment of Hypertensive Patients with Metabolic Syndrome.Irbesartan en el tratamiento del paciente hipertenso con síndrome metabólico
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 540
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) Subjects must be willing and able to provide written informed consent.
- •2) Uncontrolled hypertension defined as an averaged SeSBP =140 mmHg and/or an
- •averaged SeDBP =90 mmHg. Applies to both drug naive, and subjects receiving antihypertensive monotherapy.
- •3) Presenting at least 2 characteristics of metabolic syndrome other than BP, defined
- •according to the modified ATPIII* criteria and confirmed prior to randomization.
- •Obesity confirmed by Waist circumference:
- •Men >94 cm (>37 in)
- •Women >80 cm (>32 in)
- •Triglycerides >150 mg/dL
- •HDL cholesterol
- •Men <40 mg/dL
- •Women <50 mg/dL
- •Fasting plasma glucose =100 mg/dL (5.6 mmol/L) additionally, <126 mg/dL (7.0 mmol/L)
- •4) Men and women, ages =18 years
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and up to four Weeks after the study in such a manner that the risk of pregnancy is minimized.
- •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
- •1) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period and for up to 4 Weeks after the study or Women who are pregnant or breastfeeding.
- •2) Subjects treated with any antidiabetic/antihyperglycemic medication, or with a fasting blood glucose =126 mg/dL.
- •3) SeSBP =180 mmHg and/or SeDBP =110 mmHg and/or evidence of malignant or
- •accelerated hypertension or clinical evidence that the subject requires immediate
- •lowering of their blood pressure within hours.
- •4) Known or suspected secondary hypertension.
- •5) Previous treatment with an ARB or ACE inhibitors within 4 months prior to
- •enrollment.
- •6) Hypertensive encephalopathy, stroke, or transient ischemic attack within the past
- •7) Myocardial infarction, percutaneous transluminal coronary revascularization,
- •coronary artery bypass graft, or unstable angina pectoris within the past six months.
- •8) New York Heart Association (NYHA) functional class III-IV congestive heart failure,
- •or LV dysfunction requiring an ACE inhibitor or ARB.
- •9) Hemodynamically significant cardiac valvular disease
- •10) Heart block greater than first degree atrioventricular block, or preexcitation
- •syndrome, sick sinus syndrome, chronic atrial fibrillation, or chronic atrial flutter, or
- •other significant arrhythmias that may interfere with the blood pressure
- •measurements.
- •11) Significant chronic renal impairment, or renovascular disease
- •12) Significant liver disease
- •13) Systemic lupus erythematosus or other chromic autoimmune disease (with exception of Graves-Basadov disease).
- •14) Gastrointestinal disease or surgery that may interfere with drug absorption
- •15) Malignancy during the past five years (with exception of localized squamous cell or basal cell carcinoma of the skin, and/or local papillomas requiring no systemic
- •treatment).
- •16) Drug or alcohol abuse within the last five years
- •17) Non-fasting serum glucose =200 mg/dL (11.1 mmol/L), fasting serum glucose =126 mg/dL (6.9 mmol/L) [Analysis may be repeated once, if initial result is out of
- •18) Serum potassium < 3.3 or > 5.5 mmol/L [Analysis may be repeated once, if initial
- •result is out of range.]
- •19) Positive appearance of blood in the urine
- •20) Known hypersensitivity to irbesartan (or any other ARB), or HCTZ.
- •21) Oral or intramuscular corticosteroids and anabolic steroids are prohibited. (Only
- •short-term use of topical steroids and inhaled corticosteroids are allowed. No chronic
- •use permitted)
- •22) Any open-label antihypertensive medications (registered for the treatment of HTN
- •regardless of actual current indication)
- •23) Nitrates, and other vasodilators
- •24) Phosphodiesterase inhibitors for the treatment of erectile dysfunction (sildenafil,
- •tadalafil, and vardenafil) should not be taken in the 24 hours prior to any study visits
- •25) Chronic sympathomimetic drugs including bronchodilators, nasal sprays and oral
- •decongestants
- •26) Other bronchodilators
- •27) Potassium supplements
- •28) Lithium
- •29) Psychotropic drug therapy, anticonvulsant and antidepressant drugs
- •30) Antibiotics other than short (= 2 Week) courses
- •31) Protease inhibitors and reverse transcriptase inhibitors
- •32) Chronic NSAIDs, including COX-2 inhibitors (chronic defined as for seven days or
- •more) with the exception of low-dose aspirin therapy and occasional aspirin or NSAID use in customary doses
- •33) The use of fibrates within 12 months prior to entry into the Lead-In Phase are
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