Trial intelligence / Profile preview

Aliskiren vs Ramipril in Moderate Systolic Hypertension

NCT01042392Phase 4

Key facts

Status: Completed
Start: Nov 2009
Primary completion: Jan 2011
Countries: 1
Sponsor: Novartis
Modality: Small Molecules

Drugs: aliskiren
Conditions: essential hypertension

Overview

Phase 4, randomised, double-blind trial of aliskiren in essential hypertension (2 arms), sponsored by Novartis. Primary endpoint: Change From Baseline in Mean Sitting Systolic Blood Pressure at 8 weeks. Started Nov 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Aliskiren
Aliskiren 150 mg titrated to 300 mg.
Ramipril
Ramipril 5 mg titrated to 10 mg.

Who it enrols

Adult outpatients with essential hypertension previously treated with single-drug therapy (uncontrolled or intolerant). Exclusion for severe hypertension, secondary hypertension, or history of heart failure/stroke.

Endpoints

Primary

Change From Baseline in Mean Sitting Systolic Blood Pressure8 weeks

Secondary

Change From Baseline in Mean Sitting Diastolic Blood Pressure8 weeks
Percentage of Patients With Controlled Blood Pressure8 weeks
Number of Participants With More Than 55 mmHg Difference Between Morning Surge and Night Minimal SBP8 weeks
Number Patients Reported With Adverse Events, Serious Adverse Events and Death8 weeks + 1 day

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