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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

362

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Hypertension
Interventions
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"

DRUG

placebo

Cohorts A, B, C: placebo, once daily

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"

Trial Locations (65)

5200

Eastern Cape

7130

Western Cape

7764

Cape Town

9300

Bloemfontein

33647

Tampa

85013

Phoenix

90049

Los Angeles

Unknown

Birmingham

Little Rock

Beverly Hills

Fresno

Washington D.C.

Jacksonville

Miami

Orlando

Decatur

Honolulu

Park Ridge

New Orleans

Shreveport

Baltimore

Grand Rapids

Las Vegas

Hackensack

New Brunswick

Kinston

Cincinnati

Dayton

Portland

Beaumont

Houston

Charlottesville

San Miguel de Tucumán

Bahía Blanca

Buenos Aires

Capital Federal

Mar del Plata

Campinas

Curitiba

Porto Alegre

Recife

São Paulo

Santiago

Bogotá

Cali-Valle

Ahmedabad

Mangalore

Vellore

Trivandrum

Lucknow

Chandigarh

Tamil Nadu

Nairobi

Lima

Durban, KZ-Natal

E Cape

Park Town, Gauteng

Pietermaritzburg, KZ-Natal

Potchefstroom, Northwest

Pretoria, Gauteng

Kampala

Kitwe

Lusaka

500 033

Hyderabad

110 029

New Delhi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY