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临床试验/EUCTR2005-000614-12-DE
EUCTR2005-000614-12-DE进行中（未招募）不适用

Irbesartan in the treatment of Hypertensive Patients with Metabolic Syndrome.Revised Protocol 2, incorporating Protocol Amendments 01 dated 09-Jan-06 & 02 dated 05-Oct-2006. And Protocol amendment 03 dated 24-Oct-2006 - Biomarkers Substudy.

Bristol Myers Squibb International Corporation0 个研究点目标入组 540 人开始时间: 2006年5月16日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
540
研究概览入排标准研究者记录与标识符相似试验

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.
  • •A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
  • •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 (calculated Glomerular Filtration Rate =30ml/min), 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 plasma glucose =200 mg/dL (11.1 mmol/L), fasting plasma glucose =126 mg/dL (7.0 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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