Status:
COMPLETED
Renin Profiling in Selection of Initial Antihypertensive Drug
Lead Sponsor:
The Louis & Rachel Rudin Foundation
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Hypertension
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
The purpose of this research study is to determine whether a simple blood test measuring a hormone called renin can better determine which first drug would be most effective in controlling blood press...
Detailed Description
Hypothesis: That antihypertensive drug selection guided by activity of the renin angiotensin system will be superior to the strategy advocated in JNC 7 in achieving blood pressure control on monothera...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Males and females, 40 to 85 years of age
- Sustained systolic blood pressure between 140-180 mm Hg
- Free of antihypertensive therapy at randomization for at least 4 weeks
- Exclusion criteria:
- Ages \<40, or \>85 years
- Systolic blood pressure \>180 mm Hg
- Blood pressure \>180/105 mm Hg during the washout period
- Require antihypertensive agents for non-blood pressure indications
- Taking clonidine
- On a beta-blocker drug and have known or suspected coronary artery disease
- Documented history of a heart attack, new onset of chest pain, or a coronary revascularization procedure within the past year, congestive heart failure
- Serious intercurrent illness
- An active ulcer
- Have certain abnormal laboratory tests (elevated serum creatinine \>1.5 mg/dl, transaminase \> 2 times upper limit of normal or active liver disease),
- Hypersensitivity, allergy or have an intolerance to angiotensin II receptor blockers (olmesartan), hydrochlorothiazide or amlodipine
- Mentally or legally unable to participate
- Have or are currently abusing alcohol, have abused drugs within the past 2 years
- Have been in another drug study in the past month.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00834600
Start Date
December 1 2005
End Date
October 1 2011
Last Update
April 19 2012
Active Locations (5)
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1
Lincoln Medical and Mental Health Center
The Bronx, New York, United States, 10451
2
Albert Einstein College of Medicine - GCRC
The Bronx, New York, United States, 10461
3
Jacobi Medical Center
The Bronx, New York, United States, 10461
4
Bronx Nephrology Hypertension, PC
The Bronx, New York, United States, 10467