Aliskiren Study of Safety and Efficacy in Senior Hypertensives

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2015

Primary Completion Date

June 30, 2018

Study Completion Date

June 30, 2018

Conditions
Hypertension
Interventions
DRUG

Aliskiren

Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.

DRUG

Amlodipine

Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.

DRUG

Ramipril

Ramipril 5 mg and ramipril 10 mg capsules will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.

DRUG

Hydrochlorothiazide

Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY