Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension

A Study to Evaluate the Safety and Efficacy of Valsartan/Amlodipine Compared to Lisinopril/Hydrochlorothiazide Given Once Daily for 6 Weeks is Patients With Severe Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171535

Enrollment

130

Registered

2005-09-15

Start date

2004-10-31

Completion date

2005-04-30

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, high blood pressure, valsartan, amlodipine

Brief summary

This study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension

Interventions

DRUGvalsartan/amlodipine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Patients with severe hypertension

Exclusion criteria

* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm * Liver, kidney, or pancreas disease * Insulin dependent diabetes * Allergy to certain medications used to treat high blood pressure Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Adverse events and serious adverse events at each study visit for 6 weeks	—

Secondary

Measure	Time frame
Sitting and standing blood pressure measurements after 6 weeks	—
Laboratory test data after 6 weeks	—
Vital signs at each study visit for 6 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026