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I-COMBINE: Irbesartan/Amlodipine vs Amlodipine in Hypertension

NCT00956644Phase 3

Key facts

Status: Completed
Start: Jul 2009
Primary completion: Aug 2010
Countries: 9
Sponsor: Sanofi
Modality: Small Molecules

Drugs: irbesartan
Conditions: hypertension (HTN)

Overview

Phase 3, randomised, open-label trial of irbesartan in hypertension (HTN) (2 arms), sponsored by Sanofi. Primary endpoint: Mean home systolic blood pressure at 5 weeks. Started Jul 2009; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

irbesartan/amlodipine
Fixed combination therapy
amlodipine
Monotherapy active control

Endpoints

Primary

Mean home systolic blood pressure5 weeks

Secondary

Mean office blood pressure10 weeks
Mean home diastolic blood pressure10 weeks
Incidence and severity of adverse events

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