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

NCT ID: NCT00151775

Last Updated: 2016-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-09-30

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

olmesartan medoxomil

Intervention Type: DRUG

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

Period 3

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

Group Type: EXPERIMENTAL

olmesartan medoxomil

Intervention Type: DRUG

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

placebo

Intervention Type: DRUG

Cohorts A, B, C: placebo, once daily

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

Group Type: EXPERIMENTAL

olmesartan medoxomil

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

placebo

Cohorts A, B, C: placebo, once daily

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Benicar (olmesartan medoxomil); Benicar (olmesartan medoxomil)

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Beverly Hills, California, United States

Fresno, California, United States

Los Angeles, California, United States

Washington D.C., District of Columbia, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

Decatur, Georgia, United States

Honolulu, Hawaii, United States

Park Ridge, Illinois, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Baltimore, Maryland, United States

Grand Rapids, Michigan, United States

Las Vegas, Nevada, United States

Hackensack, New Jersey, United States

New Brunswick, New Jersey, United States

Kinston, North Carolina, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Portland, Oregon, United States

Beaumont, Texas, United States

Houston, Texas, United States

Charlottesville, Virginia, United States

San Miguel de Tucumán, TUC, Argentina

Bahía Blanca, , Argentina

Buenos Aires, , Argentina

Capital Federal, , Argentina

Mar del Plata, , Argentina

Campinas, , Brazil

Curitiba, , Brazil

Porto Alegre, , Brazil

Recife, , Brazil

São Paulo, , Brazil

Santiago, , Chile

Bogotá, , Colombia

Cali-Valle, , Colombia

Ahmedabad, Gujarat, India

Mangalore, Karna, India

Vellore, Karna, India

Trivandrum, Kerala, India

Lucknow, Uttar Prad, India

Chandigarh, , India

Hyderabad, , India

New Delhi, , India

Tamil Nadu, , India

Nairobi, , Kenya

Lima, , Peru

Bloemfontein, , South Africa

Cape Town, , South Africa

Durban, KZ-Natal, , South Africa

E Cape, , South Africa

Eastern Cape, , South Africa

Park Town, Gauteng, , South Africa

Pietermaritzburg, KZ-Natal, , South Africa

Potchefstroom, Northwest, , South Africa

Pretoria, Gauteng, , South Africa

Western Cape, , South Africa

Kampala, , Uganda

Kitwe, , Zambia

Lusaka, , Zambia

Countries

United States; Argentina; Brazil; Chile; Colombia; India; Kenya; Peru; South Africa; Uganda; Zambia

Other Identifiers

CS0866-A-U301

Identifier Type: -

Identifier Source: org_study_id