Study to Evaluate the Safety and Efficacy of Two Fixed Dose Combinations of Irbesartan / Amlodipine and Monotherapy After Eight Weeks of Treatment in Subjects With Uncomplicated Mild to Moderate Essential Hypertension (I-COMBO)

NCT00950066 Phase 2 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 2
Status	COMPLETED
Enrolment	270
Start date	2009-07
Completion	2010-01

Conditions

• Hypertension

Interventions

• IRBESARTAN (SR47436)
• Amlodipine
• Irbesartan / Amlodipine
• Placebo

Primary outcomes

• Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo — At week 0, week 2, week 4 and week 8

Countries

India, Philippines, South Korea, Taiwan