Status:
COMPLETED
A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
Integrium
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who ...
Eligibility Criteria
Inclusion
- \>= to 18 years of age
- Hypertension uncontrolled on current monotherapy
- Females:
- negative serum pregnancy test at screening
- post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control
Exclusion
- Pregnant females
- Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene
- Diabetes requiring insulin
- Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment
- History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months
- History of Class III or IV congestive heart failure
- History of stroke or transient ischemic attack within the last 1 year
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
999 Patients enrolled
Trial Details
Trial ID
NCT00791258
Start Date
November 1 2008
End Date
September 1 2009
Last Update
January 9 2019
Active Locations (72)
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1
Birmingham, Alabama, United States
2
Green Valley, Arizona, United States
3
Mesa, Arizona, United States
4
Sierra Vista, Arizona, United States