The Relative Effects of Olmesartan Medoxomil, Irbesartan and Valsartan on the Activity of the Blood Pressure Control System in Healthy Subjects

September 15, 2005 updated by: Daiichi Sankyo, Inc.

The Relative Effects of Single Doses of Olmesartan Medoxomil, Irbesartan and Valsartan at High Dosage Levels on the Renin-Angiotensin-Aldosterone System in Healthy Normal Subjects

To assess the effects of 3 blood pressure drugs, called angiotensin receptor blockers, on the blood pressure control systems in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women between the ages of 18 to 65
  • In good health

Exclusion Criteria:

  • Any serious health problems
  • Positive test for HIV, Hepatitis B and C
  • History of drug and alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To characterize the plasma renin activity (PRA) and urinary aldosterone response patterns to single doses of olmesartan medoxomil, irbesartan, and valsartan compared to placebo in normal volunteers.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 16, 2005

Last Update Submitted That Met QC Criteria

September 15, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 866-448

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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