drugset / Trial / NCT01625494

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

NCT01625494

Phase 3 Completed 158 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-05
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 5 mg Oral
Subject Amlodipine Other / unclassified 10 mg Oral
Subject Irbesartan Small molecule 150 mg Oral
Subject Irbesartan Small molecule 300 mg Oral

Indications