Irbesartan in the treatment of Hypertensive Patients with Metabolic Syndrome.Irbesartan en el tratamiento del paciente hipertenso con síndrome metabólico
- Conditions
- Hypertension, nos
- Registration Number
- EUCTR2005-000614-12-ES
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
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
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
12 months.
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
range.]
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
prohibited, as well as during the course of the study
34) Statins
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method