Status:
COMPLETED
Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypertension
Eligibility:
All Genders
1-16 years
Phase:
PHASE2
PHASE3
Brief Summary
This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue t...
Detailed Description
This was a randomized, multicenter, double-blind, parallel-group, prospective dose-ranging study in subjects 1 to 16 years of age with hypertension. Subjects were enrolled into 1 of 3 cohorts based on...
Eligibility Criteria
Inclusion
- The patient's seated systolic BP (SeSBP) will be greater than or equal to 95th percentile for gender and height-for- age, or greater than or equal to 90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension.
- Negative for hepatitis B and C
- Negative for HIV
Exclusion
- Patient should not have serious other conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patient in the trial.
- Known sensitivity to olmesartan medoxomil
- Taking prohibited medication
- Consumed greater than 180 mg of caffeine daily
- Malignant hypertension
- History of congestive heart failure, cardiomyopathy, or obstructive valve disease
- Renal transplant within the previous 6 months
- Severe nephritic syndrome not in remission
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00151775
Start Date
May 1 2005
End Date
September 1 2008
Last Update
June 30 2016
Active Locations (65)
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1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States, 85013
3
Little Rock, Arkansas, United States
4
Beverly Hills, California, United States