The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
645
Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
Tablets, Oral, 150 mg, Once daily, 7 weeks.
Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5
Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.
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