- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151775
Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
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 age and race. Subjects 6 to 16 years of age were enrolled into Cohort A. Subjects enrolled into Cohort A were stratified by age with approximately half aged 6 to 12 years and the remainder aged 13 to 16 years. Approximately 15% of the subjects in Cohort A were to be Black or of African descent. When a minimum of 28 Black subjects were randomized into Cohort A, enrollment in Cohort B was started. Black subjects only, 6 to 16 years of age, were enrolled into Cohort B. For Cohorts A and B body weight of any patient was >=20Kg. Seated systolic blood pressure (SeSBP) was >=95th percentile for gender and height-for-age, or >=90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension. Patients with symptomatic hypertension requiring immediate established therapy, or who are above 2 standard deviations (SD) above the 99th percentile did not participate in the study.
Subjects 1 to 5 years of age were enrolled into Cohort C regardless of race. Body weight of any patient was >=5Kg. SeSBP was >=95th percentile for gender and height-for-age, or >=90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension. Patients on stable doses of concomitant antihypertensive agents including calcium channel blockers and/or diuretics only are permitted to enroll. Patients with symptomatic hypertension requiring immediate established therapy, or who are above 2 SD above the 99th percentile did not participate in the study.
The study comprised four periods. Period I was a wash-out period from Week -1 to randomization. Subjects were randomized to treatment sequences carried through the remainder of the study. Period II was a three-week, double-blind, dose-ranging period for Cohorts A and B, beginning at Day 1 and ending at the end of Week 3. In Cohorts A and B, subjects received either low-dose or high-dose olmesartan (OM) once daily. In Cohort C, Period II was an open-label OM treatment period where all subjects received 0.3 mg/kg OM per day. Period III was a double-blind, placebo-controlled withdrawal period beginning at Week 4 and ending after 1 or 2 weeks, depending on the seated blood pressure measurement at each weekly study visit. Subjects either continued their Period II OM regimen or switched to placebo based on the initial randomization scheme. Period IV was a 46-week open-label extension period.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Bahia Blanca, Argentina
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Mar del Plata, Argentina
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TUC
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San Miguel de Tucuman, TUC, Argentina
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Campinas, Brazil
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Curitiba, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Sao Paulo, Brazil
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Santiago, Chile
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Bogota, Colombia
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Cali-Valle, Colombia
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Chandigarh, India
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Hyderabad, India, 500 033
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New Delhi, India, 110 029
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Tamil Nadu, India
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Gujarat
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Ahmedabad, Gujarat, India
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Karna
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Mangalore, Karna, India
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Vellore, Karna, India
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Kerala
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Trivandrum, Kerala, India
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Uttar Prad
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Lucknow, Uttar Prad, India
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Nairobi, Kenya
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Lima, Peru
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Bloemfontein, South Africa, 9300
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Cape Town, South Africa, 7764
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Durban, KZ-Natal, South Africa
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E Cape, South Africa
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Eastern Cape, South Africa, 5200
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Park Town, Gauteng, South Africa
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Pietermaritzburg, KZ-Natal, South Africa
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Potchefstroom, NW, South Africa
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Pretoria, Gauteng, South Africa
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Western Cape, South Africa, 7130
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Kampala, Uganda
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Alabama
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Birmingham, Alabama, United States
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Arizona
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Phoenix, Arizona, United States, 85013
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Arkansas
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Little Rock, Arkansas, United States
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California
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Beverly Hills, California, United States
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Fresno, California, United States
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Los Angeles, California, United States, 90049
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States, 33647
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Georgia
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Decatur, Georgia, United States
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Hawaii
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Honolulu, Hawaii, United States
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Illinois
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Park Ridge, Illinois, United States
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Louisiana
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Michigan
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Grand Rapids, Michigan, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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Hackensack, New Jersey, United States
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New Brunswick, New Jersey, United States
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North Carolina
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Kinston, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Oregon
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Portland, Oregon, United States
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Texas
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Beaumont, Texas, United States
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Houston, Texas, United States
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Virginia
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Charlottesville, Virginia, United States
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Kitwe, Zambia
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Lusaka, Zambia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Period 2
For Cohorts A and B, olmesartan medoxomil suspension 2.5 mg to 40 mg in patients 6-16 years old, depending on weight. For Cohort C, olmesartan medoxomil suspension 0.3 mg/kg to in patients 1-5 years old. |
Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension. Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily
Other Names:
Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly. Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg
Other Names:
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Experimental: Period 3
Cohorts A, B, C - olmesartan medoxomil suspension or placebo taken once daily.
Olmesartan medoxomil dose continued as in previous period.
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Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension. Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily
Other Names:
Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly. Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg
Other Names:
Cohorts A, B, C: placebo, once daily
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Experimental: Period 4
Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg |
Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension. Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily
Other Names:
Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly. Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)
Time Frame: Day 0 to 3 weeks
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The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2).
Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.
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Day 0 to 3 weeks
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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)
Time Frame: Day 0 (baseline) to 3 weeks
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Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
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Day 0 (baseline) to 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Time Frame: Week 3 (period 3 baseline) to week 5 (end of Period 3)
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Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
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Week 3 (period 3 baseline) to week 5 (end of Period 3)
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Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Time Frame: Week 3 (period 3 baseline) to week 5 (end of Period 3)
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Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.
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Week 3 (period 3 baseline) to week 5 (end of Period 3)
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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Time Frame: Day 0 to week 51 (end of study)
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Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
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Day 0 to week 51 (end of study)
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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Time Frame: Day 0 to week 51 week (end of study)
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Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.
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Day 0 to week 51 week (end of study)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS0866-A-U301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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