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

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ClinicalTrials.gov Identifier: NCT00185055
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Olmesartan medoxomil Drug: Irbesartan Drug: Valsartan Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2004
Estimated Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

ClinicalTrials.gov Identifier: NCT00185055     History of Changes
Other Study ID Numbers: 866-448
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005

Keywords provided by Daiichi Sankyo, Inc.:
olmesartan
valsartan
irbesartan
renin-angiotensin-aldosterone system

Additional relevant MeSH terms:
Olmesartan
Irbesartan
Valsartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action