DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: olmesartan medoxomil (Drug); placebo (Drug); olmesartan medoxomil (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

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.

Clinical Details

Official title: Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)

Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)

Secondary outcome:

Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)

Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)

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.

Eligibility

Minimum age: 1 Year. Maximum age: 16 Years. Gender(s): Both.

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

Locations and Contacts

Bahia Blanca, Argentina

Buenos Aires, Argentina

Capital Federal, Argentina

Mar del Plata, Argentina

Campinas, Brazil

Curitiba, Brazil

Porto Alegre, Brazil

Recife, Brazil

Sao Paulo, Brazil

Santiago, Chile

Bogota, Colombia

Cali-Valle, Colombia

Chandigarh, India

Hyderabad 500 033, India

New Delhi 110 029, India

Tamil Nadu, India

Nairobi, Kenya

Lima, Peru

Bloemfontein 9300, South Africa

Cape Town 7764, South Africa

Durban, KZ-Natal, South Africa

E Cape, South Africa

Eastern Cape 5200, South Africa

Park Town, Gauteng, South Africa

Pietermaritzburg, KZ-Natal, South Africa

Potchefstroom, NW, South Africa

Pretoria, Gauteng, South Africa

Western Cape 7130, South Africa

Kampala, Uganda

Kitwe, Zambia

Lusaka, Zambia

Birmingham, Alabama, United States

Phoenix, Arizona 85013, United States

Little Rock, Arkansas, United States

Beverly Hills, California, United States

Fresno, California, United States

Los Angeles, California 90049, United States

Washington, District of Columbia, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Tampa, Florida 33647, United States

Decatur, Georgia, United States

Ahmedabad, Gujarat, India

Honolulu, Hawaii, United States

Park Ridge, Illinois, United States

Mangalore, Karna, India

Vellore, Karna, India

Trivandrum, Kerala, India

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

San Miguel de Tucuman, TUC, Argentina

Beaumont, Texas, United States

Houston, Texas, United States

Lucknow, Uttar Prad, India

Charlottesville, Virginia, United States

Additional Information

Starting date: May 2005
Last updated: May 20, 2010

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017