The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo. The secondary objectives are: * to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo. * to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
270
Oral administration of Irbesartan 150mg or 300mg once a day
Oral administration of Amlodipine 5mg once a day
Oral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day
Sanofi-Aventis Administrative Office
Mumbai, India
Sanofi-Aventis Administrative Office
Makati City, Philippines
Sanofi-Aventis Administrative Office
Seoul, South Korea
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo
Time frame: At week 0, week 2, week 4 and week 8
Difference in mean change in SeSBP between each FDC, its individual constituents administered as monotherapy and placebo
Time frame: At week 0, week 2, week 4 and week 8
Difference in mean change in SeDBP and SeSBP between each FDC, its individual constituents administered as monotherapy and placebo
Time frame: At week 0, week 2, week 4
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Oral administration of a placebo once a day