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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
This study has been completed.
Sponsored by: Daiichi Sankyo Inc.
Information provided by: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00185055
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Olmesartan medoxomil
Drug: Irbesartan
Drug: Valsartan
Phase IV

Drug Information available for: Valsartan Aldosterone Irbesartan Olmesartan Olmesartan medoxomil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: November 2004
Estimated Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study ID Numbers: 866-448
Study First Received: September 9, 2005
Last Updated: September 15, 2005
ClinicalTrials.gov Identifier: NCT00185055  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Irbesartan
Olmesartan medoxomil
Healthy
Angiotensin II
Valsartan

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009