A Prospective Open-label Multicentre Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg or Amlodipine 5 mg Monotherapy

NCT01625494 Phase 3 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	158
Start date	2012-05
Completion	2013-01

Conditions

• Hypertension

Interventions

• Irbesartan/Amlodipine (150/5mg)
• Irbesartan/Amlodipine (150/10mg)
• Irbesartan/Amlodipine (300/5mg)
• Irbesartan/Amlodipine (300/10mg)

Primary outcomes

• Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study — up to 16 weeks

Countries

Russia