Olmesartan as an add-on to Amlodipine in Hypertension

Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00220233

Enrollment

632

Registered

2005-09-22

Start date

2005-04-30

Completion date

2007-08-31

Last updated

2018-12-24

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

Conditions

Essential Hypertension

Brief summary

This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone

Interventions

DRUGolmesartan medoxomil

DRUGamlodipine

DRUGhydrochlorothiazide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg * Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg

Exclusion criteria

* Secondary hypertension * Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Design outcomes

Primary

Measure	Time frame
Mean change in trough seated diastolic blood pressure	—

Secondary

Measure	Time frame
Mean change in trough seated systolic BP	—
Mean change in daytime, nighttime and 24 hour ambulatory blood pressure	—
Percent of patients achieving target blood pressure goal	—
Safety and tolerability	—

Countries

Germany

Outcome results

None listed

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