Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

965

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Hypertension
Interventions
DRUG

Amlodipine 5 mg

1 capsule amlodipine 5 mg orally once daily

DRUG

Valsartan 80 mg

1 capsule valsartan 80 mg orally once daily

DRUG

Valsartan 40 mg

1 capsule valsartan 40 mg orally once daily

DRUG

Placebo

1 capsule placebo to match valsartan orally once daily

Trial Locations (18)

Unknown

Novartis Investigative site, Brno

Investigative site Czech Republic, Chrudim

Investigative sites Czech Repbulic, Hodonín

Investigative site Czech Repbulic, Jičín

Sites in Czech Republic, Náchod

Investigative sites Czech Republic, Prague

Investigative site Finland, Helsinki

Investigative site Finland, Joensuu

Investigative site Finland, Kerava

Investigative site Finland, Tampere

Investigative site France, Paris

Investigative site Germany, Berlin

Investigative site Hungary, Budapest

Investigative site Italy, Rome

Investigative site Poland, Warsaw

Investigative site Slovakia, Bratislava

Investigative site Spain, Valencia

Investigative site Sweden, Malmo

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY