Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone

Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 mg Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00170963

Enrollment

1018

Registered

2005-09-15

Start date

2004-10-31

Completion date

2005-06-30

Last updated

2017-05-17

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 test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

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 uncomplicated, essential hypertension

Exclusion criteria

* Severe hypertension * 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in diastolic blood pressure after 8 weeks	—

Secondary

Measure	Time frame
Change from baseline in mean systolic blood pressure after 8 weeks	—
Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was less than 90 mmHg after 8 weeks	—
Diastolic blood pressure less than 90 mmHg after 8 weeks	—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026