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Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension

NCT01001572 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 932

Last updated 2011-05-24

Study results available
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Summary

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.

Conditions

  • Essential Hypertension

Interventions

DRUG

Valsartan/amlodipine 160/5 mg

Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.

DRUG

Valsartan 160 mg

Valsartan 160 mg capsule taken orally once daily.

DRUG

Placebo

1 capsule or tablet taken orally once daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001572 on ClinicalTrials.gov