Overview

Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy

Status:
Completed

Trial end date:
2013-01-01

Target enrollment:

Participant gender:

Summary

Primary Objective: - To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure < 140 mmHg and Diastolic blood pressure <90mmHg, at the end of the study Secondary Objectives: - To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure) - To examine the proportion of patients with controlled OBPM (systolic BP<140 mm Hg and diastolic BP<90 mmHg) of the different dose groups over time - To determine the incidence and severity of adverse events.

Phase:

Phase 3

Details

Lead Sponsor:

Sanofi

Treatments:

Amlodipine
Irbesartan