Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

A Randomized, Double-blind, Placebo-controlled Factorial Study Evaluating the Efficacy and Safety of Co-administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185133

Enrollment

1900

Registered

2005-09-16

Start date

2005-05-31

Completion date

2007-01-31

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

Hypertension

Keywords

Treatment of high blood pressure in mild to severe hypertensive patients

Brief summary

This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age

Interventions

DRUGOlmesartan medoxomil

DRUGAmlodipine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female patients * 18 years of age or older (20% equal to or older than 65 years) * With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication

Exclusion criteria

* Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

Design outcomes

Primary

Measure	Time frame
Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm	—

Secondary

Measure	Time frame
To evaluate the number (%) of patients achieving BP goal.	—
To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation	—

Countries

United States

Outcome results

None listed

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