Severe Hypertension
Conditions
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Subjects must have uncontrolled hypertension defined as: • currently untreated with an SeDBP = 110mmHg OR • 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
Exclusion criteria
Exclusion criteria: * 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 5.5 mmol/l * White blood cell count < 2,600/µl * Platelet count < 100,000/µl * Hb < 10g/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the proportion of subjects whose seated diastolic blood pressure (SeDBP) is controlled (SeDBP < 90mmHg) at Week 5 when initiating irbesartan 150mg/HCTZ 12.5mg combination therapy as first-line treatment (titrated to irbesartan 300mg/HCTZ 25mg), as compared to initiating irbesartan 150mg monotherapy and titrating to irbesartan 300mg. ;Secondary Objective: To characterize the safety/tolerability in the two treatment groups over the sevenweek study period, examining in particular the frequency of treatment discontinuations due to adverse events, the frequencies of hypotension, dizziness and syncope, the frequency of headaches, and the frequencies of hypokalemia and hyperkalemia.;Primary end point(s): The primary efficacy outcome measurements is the proportion of subjects with seated diastolic blood pressure less than 90 mmHg at the end of Week 5. | — |
Countries
Belgium
Outcome results
None listed