Moderate Hypertension
Conditions
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Subjects must have uncontrolled hypertension defined as: Untreated Subjects: • averaged SeSBP >= 160mmHg and = 100mmHg and = 130mmHg and = 150mmHg and = 95mmHg and = 130mmHg and = 160mmHg and = 100mmHg and = 130mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to one week after the study. * SeSBP >= 180mmHg or SeDBP >= 110mmHg 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. * 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 black, preexcitation syndrome, sick sinus syndrome, chronic atrial fibrillation, or chronic atrial flutter, or other significant arrhythmias that may interfere with the blood pressure measurements * Obesity that would limit accurate blood pressure measurement * Concomitant vasoactive drugs, including the following, are not permitted throughout the study: - Nitrates - ACE inhibitors, calcium antagonists, diuretics, angiotensin II receptor antagonists - Beta-adrenergic blocking agents including eye drops - Chronic sympathomimetic drugs including bronchodilators, nasal sprays and oral decongestants - Other bronchodilators - Other antihypertensive drugs and arterial vasodilators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the change from baseline in SeSBP between the first-line combination arm and each of the two monotherapy arms at Week 8.;Secondary Objective: • To characterize the safety/tolerability in the two treatment regimens over twelve weeks of active therapy, 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. • To compare the change from baseline in SeDBP between the first-line combination arm and each of the two monotherapy arms at Weeks 8 and 12 • To compare the change from baseline in SeSBP between the first-line combination arm and each of the two monotherapy arms at Week 12 • To compare the proportion of subjects with simultaneous SeSBP < 140 mmHg and SeDBP < 90 mmHg between the first-line combination arm and each of the two monotherapy arms at Weeks 8 and 12 • To examine the change from baseline in hs-CRP at Week 12. ;Primary end point(s): * The primary efficacy variable is the change in SeSBP from baseline to Week 8. | — |
Countries
Germany
Outcome results
None listed