The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients with Moderate Hypertensio
- Conditions
- Moderate Hypertension
- Registration Number
- EUCTR2004-000033-11-DE
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 496
* Subjects must have uncontrolled hypertension defined as:
Untreated Subjects:
• averaged SeSBP >= 160mmHg and <180mmHg, and averaged SeDBP <110 mmHg
or
•averaged SeDBP >= 100mmHg and <110mmHg and averaged SeSBP >= 130mmHg and <180mmHg
Subjects Receiving Antihypertensive Monotherapy:
• averaged SeSBP >= 150mmHg and <180mmHg, and averaged SeDBP <110mmHg
or
• averaged SeDBP >= 95mmHg and <110mmHg and averaged SeSBP >= 130mmHg and <180mmHg.
Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy.
* To qualify for randomization to double-blind therapy:
• averaged SeSBP >= 160mmHg and <180mmHg, and averaged SeDBP <110mmHg
or
• averaged SeDBP >= 100mmHg and <110mmHg, and averaged SeSBP >= 130mmHg and <180mmHg off of medication must be demonstrated at Visits A01 and A99 prior to randomization (see Section 7.3.4 for instructions and standardization of measurements).
* Men and women, ages 18 and older will be included.
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week 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
* 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
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