To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
992
Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows: Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes: * Losartan 50 mg * Losartan 100 mg * Losartan 100 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 25 mg * Losartan 100 mg/HCTZ 25 mg + CCB Patients with severe hypertension: * Losartan 50 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 25 mg * Losartan 100 mg/HCTZ 25 mg + CCB * Losartan 100 mg/HCTZ 25 mg + increasing CCB
Low-salt intake diet (Dietary Approaches to Stop Hypertension \[DASH\]) including: * Healthy diet * Reduction in sodium intake to less than 2300 mmol/day * Low alcohol consumption (less than 2 standard drinks/day)
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment
Time frame: 14 Weeks
Change in Systolic Blood Pressure From Baseline to Week 14
Time frame: 14 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 14
Time frame: 14 Weeks
Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline
Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment
Time frame: 6 Weeks
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline
Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment
Time frame: 10 Weeks
Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline
Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment
Time frame: 40 Weeks
Change in Systolic Blood Pressure From Baseline to Week 6
Time frame: 6 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 6
Time frame: 6 Weeks
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Change in Systolic Blood Pressure From Baseline to Week 10
Time frame: 10 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 10
Time frame: 10 Weeks
Time to Achieve the Target Blood Pressure From Baseline
Time to achieve the target blood pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics).
Time frame: 14 Weeks