Hypertension, nos
Conditions
Interventions
Trade Name: Karvea
Product Name: Karvea
Product Code: 186295-A150-105
Pharmaceutical Form: Tablet
INN or Proposed INN: Irbesartan
CAS Number: 138402-11-6
Current Sponsor code: BMS-186295
Other descrip
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the change from baseline in insulin resistance (IR, as measured by the Matsuda Index) in patients with hypertension and metabolic syndrome after 16 Weeks of monotherapy treatment with irbesartan relative to HCTZ.;Secondary Objective: 1) To compare the change from baseline in insulin resistance (IR, as measured by the Quicki Index) after 16 Weeks of monotherapy treatment with irbesartan relative to HCTZ. 2) To compare the change from baseline in triglycerides, in BP, in hs-CRP after 16 Weeks of monotherapy treatment with irbesartan relative to HCTZ. 3) To compare the change from baseline in albumin/creatinine ratio after 16 Weeks of monotherapy treatment with irbesartan relative to HCTZ. 4) To describe the changes from baseline in Matsuda Index, Quicki index, BP, triglycerides, hs-CRP, and albumin/creatinine ratio after 28 Weeks of treatment with a regimen of irbesartan + HCTZ. 5) To describe the changes from Week 16 to Week 28 in Matsuda Index, Quicki index, BP, and triglycerides in the two randomized treatment groups. 6) To assess the safety and tolerability of irbesartan and HCTZ alone and in combination. ;Primary end point(s): The primary efficacy outcome measure is the change in insulin resistance (IR) from baseline to Week 16. The change in insulin resistance from baseline will be evaluated again at Week 28. Other efficacy measures will be to compare the change from baseline in other metabolic parameters, and seated systolic (SeSBP) and diastolic (SeDBP) blood pressures at Weeks 16 and 28 between treatment groups. Clinical adverse events and laboratory measurements will assess safety outcomes. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed