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NCT00220233 Clinical Trial

Olmesartan as an add-on to Amlodipine in Hypertension

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00220233
Other study ID # CS8663-A-E303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2005
Est. completion date August 2007

Study information
Verified date December 2007
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 632
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• olmesartan medoxomil

• amlodipine

• hydrochlorothiazide

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sankyo Pharma Gmbh

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in trough seated diastolic blood pressure
Secondary Mean change in trough seated systolic BP
Secondary Mean change in daytime, nighttime and 24 hour ambulatory blood pressure
Secondary Percent of patients achieving target blood pressure goal
Secondary Safety and tolerability
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