A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

Last updated: June 6, 2012
Sponsor: Pfizer
Overall Status: Terminated

Phase

3

Condition

Stress

Williams Syndrome

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT00389519
K726-06-4003
  • Ages 6-16
  • All Genders

Study Summary

The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Previous, documented diagnosis of hypertension, or newly diagnosed hypertensionaccording to the fourth report on the diagnosis, evaluation and treatment of highblood pressure in children and adolescents (United States). SiSBP greater than orequal to the 95th percentile for age, gender, and height.

  2. The subject can be safely withdrawn from antihypertensive medications during thescreening period, and if given placebo during the treatment period in the judgment ofthe Investigator.

  3. The subject is male or female age 6 to 16 years (inclusive), and weighs greater thanor equal to 20 kg.

  4. Female subjects greater than or equal to 12 years of age, or who have had greater thanor equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptablemethod of contraception.

  5. Parents/guardians are able to demonstrate their ability to (a) use a home bloodpressure monitor supplied for the study to monitor their child's blood pressure, and (2) mix and administer a liquid dose of study drug if needed.

Exclusion

Exclusion Criteria:

  1. Bilateral renal artery stenosis.

  2. Uncorrected coarctation of the aorta or corrected coarctation with a right arm/rightleg blood pressure gradient greater than 10 mmHg.

  3. Severe hypertension.

  4. Renal transplantation or other previous solid organ transplantation less than 6 monthsprior to entering the study.

  5. Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone orcyclosporine.

  6. A history of cardiomyopathy, clinically significant structural heart disease, oratrioventricular conduction disturbance, sick sinus syndrome, atrial flutter, atrialfibrillation, clinically significant bradycardia or an accessory bypass tract, orclinical symptoms of congestive heart failure.

  7. Clinically significant hematologic, hepatobiliary, or renal disease including aSchwartz formula GFR less than 40 mL/min/1.73 m2, and/or serum potassium (K+) greaterthan 5.5 mEq/L.

  8. History of pancreatitis (active or inactive).

  9. Known sensitivity to angiotensin converting enzyme inhibitors or a history ofangioneurotic edema.

Study Design

Total Participants: 422
Study Start date:
October 01, 2006
Estimated Completion Date:
November 30, 2007

Study Description

Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years. Approximately 450 children will be given placebo, or 1 of the 3 doses of ramipril. The treatment assigned will be done by chance, like flipping a coin. Approximately 120 study centers throughout the world will participate in the trial.

Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drug(s), a 4-week Treatment Period where they will receive placebo or one of the ramipril doses, and a Follow-up visit 1 week after completion of the Treatment Period. Children diagnosed with hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (U.S. report), will be included in the study if their blood pressure meets certain values.

Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed. In addition, a child's parents/guardians will be instructed to measure their child's blood pressure at home between clinic visits.

A planned interim analysis was performed after approximately 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.

Connect with a study center

  • Hospital General Interzonal "Dr. José Penna"

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Interzonal Especializado Materno Infantil

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital de Niños "Dr. Ricardo Gutiérrez"

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital de Niños Juan Carlos Navarro

    San Juan,
    Argentina

    Site Not Available

  • Centro Infantil del Rínon

    Tucomán,
    Argentina

    Site Not Available

  • Centro Infantil del Rínon

    Tucomán,
    Argentina

    Site Not Available

  • Clínica Las Condes

    Santiago,
    Chile

    Site Not Available

  • Hospital Luis Calvo Mackena

    Santiago,
    Chile

    Site Not Available

  • Hospital de Niños Roberto del Rio

    Santiago,
    Chile

    Site Not Available

  • Hospital Dr. Gustavo Fricke

    Vina del Mar,
    Chile

    Site Not Available

  • Fundación Bios

    Barranquilla,
    Colombia

    Site Not Available

  • Instituto Nacional del Riñón

    Bogotá,
    Colombia

    Site Not Available

  • Fundación Cardio Infantil - Instituto de Cardiología

    Bogotá,
    Colombia

    Site Not Available

  • Hospital de San Jose

    Bogotá,
    Colombia

    Site Not Available

  • Instituto Nacional del Riñón

    Bogotá,
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellin,
    Colombia

    Site Not Available

  • Hospital Universitario San Vicente de Paul

    Medellin,
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellín,
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellín,
    Colombia

    Site Not Available

  • Gujarat Kidney Foundation, Jivraj Mehta Hospital

    Ahmedabad,
    India

    Site Not Available

  • Heart Care Clinic

    Ahmedabad,
    India

    Site Not Available

  • St. John's Hospital

    Bangalore,
    India

    Site Not Available

  • Institute of Child Health & Hospital for Children

    Chennai,
    India

    Site Not Available

  • AIl India Institute medical sciences

    Delhi,
    India

    Site Not Available

  • Apollo Hospital

    Delhi,
    India

    Site Not Available

  • Maulana Azad Medical College and Lok Nayak Hospital

    Delhi,
    India

    Site Not Available

  • Apollo Hospital Hyderabad

    Hyderabaad,
    India

    Site Not Available

  • Nizam's Institute of Medical Sciences

    Hyderabaad,
    India

    Site Not Available

  • Christian Medical College and Hospital

    Ludhiana,
    India

    Site Not Available

  • Jaslok Hospital and Research Centre

    Mumbai,
    India

    Site Not Available

  • KEM Hospital Research Centre

    Pune,
    India

    Site Not Available

  • Kerala Institute of Medical Science

    Trivandrum,
    India

    Site Not Available

  • Klinika Nefrologii Dzieciecej SPSK nr 1 ACK AMG

    Gdansk,
    Poland

    Site Not Available

  • Katedra i Klinika Kardiologii Dzieciecej SK nr 6, Gornoslaskie Centrum Zdrowia Dziecka i Matki, Slaska AM

    Katowice,
    Poland

    Site Not Available

  • II Katedra Pediatrii, Klinika Kardiologii Dzieciecej UM w Lodzi

    Lodz,
    Poland

    Site Not Available

  • Klinika Nefrologii i Dializoterapii, Instytut Centrum Zdrowia Matki Polki

    Lodz,
    Poland

    Site Not Available

  • Klinika Kardiologii i Nefrologii Dzieciecej AM

    Poznan,
    Poland

    Site Not Available

  • I Klinika Chorob Dzieci SPSK nr 1 PAM

    Szczecin,
    Poland

    Site Not Available

  • Oddzial Nefrologi Dzieciecej ze Stacja Dializ SSP ZOZ nad Dziecklem i Mlodzieza

    Szczecin,
    Poland

    Site Not Available

  • Oddzial Pediatrii i Nefrologii ze Stacja Dializ, Wojewodzki Szpital Dzieciecy

    Torun,
    Poland

    Site Not Available

  • Klinika Nefrologii i Transplantacji Nerek, Instytut Pomnik Centrum Zdrowia Dziecka

    Warszawa,
    Poland

    Site Not Available

  • Klinika Nefrologii Pediatrycznej AM

    Wroclaw,
    Poland

    Site Not Available

  • Benmed Park Clinic

    Benoni,
    South Africa

    Site Not Available

  • Chris Hani Baragwanath

    Johannesburg,
    South Africa

    Site Not Available

  • Global Clinical Trial Centre

    Port Elizabeth,
    South Africa

    Site Not Available

  • Potchefstroom Medi-Clinic

    Potchefstroom,
    South Africa

    Site Not Available

  • Eastmed Medical centre

    Pretoria,
    South Africa

    Site Not Available

  • Jubilee CTC Jubilee Hospital

    Pretoria,
    South Africa

    Site Not Available

  • Pretoria Academic Hospital

    Pretoria,
    South Africa

    Site Not Available

  • Zuid Afrikaans Hospital

    Pretoria,
    South Africa

    Site Not Available

  • Sandton Clinical Research Centre

    Sandton,
    South Africa

    Site Not Available

  • Istanbul University Istanbul Medical Faculty Pediatric Nephrology

    Istanbul,
    Turkey

    Site Not Available

  • Marmara University Medical Faculty Pediatric Nephrology

    Istanbul,
    Turkey

    Site Not Available

  • Dokuzeylul University Medical Faculty Pediatric Nephrology

    Izmir,
    Turkey

    Site Not Available

  • Ondokummayis University Medical Faculty Pediatric Nephrology

    Samsun,
    Turkey

    Site Not Available

  • Dnepropetrovsk Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital

    Dnepropetrovsk,
    Ukraine

    Site Not Available

  • Kharkov State University,Dept. of hospital pediatric on the bases of Regional Children's Hospital

    Kharkov,
    Ukraine

    Site Not Available

  • NMU n.b. Bogomolets, on b.o. Chil. Clin.Hosp.#2, Department of Pediatrics #2

    Kiev,
    Ukraine

    Site Not Available

  • Institute of Pediatrics and Obstetrics AMS of Ukraine, Department of ecology related health problems

    Kyiv,
    Ukraine

    Site Not Available

  • Danylo Halytskiy Lviv NationalMedical University, Department of Faculty

    Lviv,
    Ukraine

    Site Not Available

  • Odessa State Medical University, Dept. of hospital pediatric and neonotology on the bases of Regional Children Hospital

    Odessa,
    Ukraine

    Site Not Available

  • Crim.St. Med. Uni. On b.o. Rep. Child.Clin.Hosp. Chair of Pediat. W.c. of Physioth. Of the Postgr.dept

    Simferopol,
    Ukraine

    Site Not Available

  • Uzhorod National University, Medical faculty, Department of Children's disease with course of Infection disease on the basis of City Children's Clinical Hospital.

    Uzhorod,
    Ukraine

    Site Not Available

  • Vinnitsa National Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital

    Vinnitsa,
    Ukraine

    Site Not Available

  • UAMS College of Medicine/ Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Woodland International Research Group, LLC

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Impact Clinical Research

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Neufeld Medical Group

    Los Angeles, California 90048
    United States

    Site Not Available

  • Almon Clinical Research, Inc.

    Orange, California 92868
    United States

    Site Not Available

  • Pediatrics in Brevard

    Cocoa Beach, Florida 33155
    United States

    Site Not Available

  • Watson Clinic Center for Research, Inc.

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Medical College of Georgia

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Hawaii Pacific Health

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Nephrology and Hypertension Consultants

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Tinley Park Pediatric Associates

    Tinley Park, Illinois 60477
    United States

    Site Not Available

  • Kosair Children's Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Louisiana State University

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Craig Spiegel, MD

    Bridgeton, Missouri 63044
    United States

    Site Not Available

  • Children's Heart Center

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Impact Clinical Trials

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Premier Clinical Research Group

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • SUNY Upstate Syracuse, Department of Pediatrics

    Syracuse, New York 13210
    United States

    Site Not Available

  • Hartrich Aquino & Hrab, PC

    Williamsville, New York 14221
    United States

    Site Not Available

  • Western Wake Pediatrics

    Cary, North Carolina 27518
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Duke Pediatric Clinical Research Program

    Durham, North Carolina 27710
    United States

    Site Not Available

  • North Carolina Children's and Adults Clinical Research Foundation

    Sylva, North Carolina 28779
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Center for Clinical and Translational Research

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • The University of Oklahoma

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Northwest Pediatric Kidney Specialists, LLC

    Portland, Oregon 97227
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97201
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • South East Texas Cardiology Associates

    Beaumont, Texas 77701
    United States

    Site Not Available

  • University of Texas Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Huguenot Pediatrics

    Midlothian, Virginia 23113
    United States

    Site Not Available

  • Children's Specialty Group

    Norfolk, Virginia 23510
    United States

    Site Not Available

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