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

Daiichi Sankyo0 sites1,900 target enrollmentMay 2005

ConditionsHypertension

DrugsOlmesartan medoxomil Amlodipine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Daiichi Sankyo
Enrollment: 1900
Primary Endpoint: Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

January 2007

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daiichi Sankyo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm

Secondary Outcomes

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