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Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure

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ClinicalTrials.gov Identifier: NCT00151775
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : April 2, 2010
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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 to take olmesartan medoxomil (OM) for up to an additional 46 weeks.

Condition or disease Intervention/treatment Phase
Hypertension Drug: olmesartan medoxomil Drug: placebo Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension
Study Start Date : May 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: olmesartan medoxomil

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 Name: Benicar (olmesartan medoxomil)

Experimental: Period 3
Cohorts A, B, C - olmesartan medoxomil suspension or placebo taken once daily. Olmesartan medoxomil dose continued as in previous period.
Drug: olmesartan medoxomil

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 Name: Benicar (olmesartan medoxomil)

Drug: placebo
Cohorts A, B, C: placebo, once daily

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

Drug: olmesartan medoxomil

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 Name: Benicar (olmesartan medoxomil)




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    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.

  4. 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) ]
    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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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151775


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Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States, 85013
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Beverly Hills, California, United States
Fresno, California, United States
Los Angeles, California, United States, 90049
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States, 33647
United States, Georgia
Decatur, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Illinois
Park Ridge, Illinois, United States
United States, Louisiana
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Grand Rapids, Michigan, United States
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Las Vegas, Nevada, United States
United States, New Jersey
Hackensack, New Jersey, United States
New Brunswick, New Jersey, United States
United States, North Carolina
Kinston, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Dayton, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Texas
Beaumont, Texas, United States
Houston, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
Argentina
San Miguel de Tucuman, TUC, Argentina
Bahia Blanca, Argentina
Buenos Aires, Argentina
Capital Federal, Argentina
Mar del Plata, Argentina
Brazil
Campinas, Brazil
Curitiba, Brazil
Porto Alegre, Brazil
Recife, Brazil
Sao Paulo, Brazil
Chile
Santiago, Chile
Colombia
Bogota, Colombia
Cali-Valle, Colombia
India
Ahmedabad, Gujarat, India
Mangalore, Karna, India
Vellore, Karna, India
Trivandrum, Kerala, India
Lucknow, Uttar Prad, India
Chandigarh, India
Hyderabad, India, 500 033
New Delhi, India, 110 029
Tamil Nadu, India
Kenya
Nairobi, Kenya
Peru
Lima, Peru
South Africa
Bloemfontein, South Africa, 9300
Cape Town, South Africa, 7764
Durban, KZ-Natal, South Africa
E Cape, South Africa
Eastern Cape, South Africa, 5200
Park Town, Gauteng, South Africa
Pietermaritzburg, KZ-Natal, South Africa
Potchefstroom, NW, South Africa
Pretoria, Gauteng, South Africa
Western Cape, South Africa, 7130
Uganda
Kampala, Uganda
Zambia
Kitwe, Zambia
Lusaka, Zambia
Sponsors and Collaborators
Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00151775     History of Changes
Other Study ID Numbers: CS0866-A-U301
First Posted: September 9, 2005    Key Record Dates
Results First Posted: April 2, 2010
Last Update Posted: June 30, 2016
Last Verified: May 2016

Keywords provided by Daiichi Sankyo, Inc.:
Treatment of hypertension or high blood pressure in children ages 1-16 years.

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action