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

This study has been terminated.
(A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00389519
First received: October 17, 2006
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: ramipril
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Arm Study Assessing the Efficacy, Safety, and Dose-Response of Ramipril for the Treatment of Hypertension in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
    Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo


Secondary Outcome Measures:
  • Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
    Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo

  • Change From Baseline to 4 Weeks in Serum Creatinine [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: Yes ]
    Value at end of treatment (up to 4 weeks) minus value at baseline

  • Change From Baseline to 4 Weeks in Serum Potassium [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: Yes ]
    Value at end of treatment (up to 4 weeks) minus value at baseline

  • Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR) [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: Yes ]
    Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.


Enrollment: 422
Study Start Date: October 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
once per day
Drug: placebo
once a day oral placebo capsule for 4 weeks
Experimental: ramipril low dose
0.3125, 0.625, or 1.25 mg once a day, based on subject weight
Drug: ramipril
once a day oral ramipril capsules given for 4 weeks
Other Name: Altace
Experimental: ramipril mid dose
1.25, 2.5, or 5 mg once a day, based on subject weight
Drug: ramipril
once a day oral ramipril capsules given for 4 weeks
Other Name: Altace
Experimental: ramipril high dose
5, 10, or 20 mg once a day, based on subject weight
Drug: ramipril
once a day oral ramipril capsules given for 4 weeks
Other Name: Altace

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previous, documented diagnosis of hypertension, or newly diagnosed hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (United States). SiSBP greater than or equal to the 95th percentile for age, gender, and height.
  2. The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.
  3. The subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.
  4. Female subjects greater than or equal to 12 years of age, or who have had greater than or 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 acceptable method of contraception.
  5. Parents/guardians are able to demonstrate their ability to (a) use a home blood pressure 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 Criteria:

  1. Bilateral renal artery stenosis.
  2. Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmHg.
  3. Severe hypertension.
  4. Renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.
  5. Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.
  6. A history of cardiomyopathy, clinically significant structural heart disease, or atrioventricular conduction disturbance, sick sinus syndrome, atrial flutter, atrial fibrillation, clinically significant bradycardia or an accessory bypass tract, or clinical symptoms of congestive heart failure.
  7. Clinically significant hematologic, hepatobiliary, or renal disease including a Schwartz formula GFR less than 40 mL/min/1.73 m2, and/or serum potassium (K+) greater than 5.5 mEq/L.
  8. History of pancreatitis (active or inactive).
  9. Known sensitivity to angiotensin converting enzyme inhibitors or a history of angioneurotic edema.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389519

  Hide Study Locations
Locations
United States, Arkansas
UAMS College of Medicine/ Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
United States, California
Impact Clinical Research
Beverly Hills, California, United States, 90211
Neufeld Medical Group
Los Angeles, California, United States, 90048
Almon Clinical Research, Inc.
Orange, California, United States, 92868
United States, Florida
Pediatrics in Brevard
Cocoa Beach, Florida, United States, 33155
Watson Clinic Center for Research, Inc.
Lakeland, Florida, United States, 33805
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Hawaii
Hawaii Pacific Health
Honolulu, Hawaii, United States, 96813
United States, Illinois
Nephrology and Hypertension Consultants
Park Ridge, Illinois, United States, 60068
Tinley Park Pediatric Associates
Tinley Park, Illinois, United States, 60477
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana State University
Shreveport, Louisiana, United States, 71103
United States, Missouri
Craig Spiegel, MD
Bridgeton, Missouri, United States, 63044
United States, Nevada
Children's Heart Center
Las Vegas, Nevada, United States, 89109
Impact Clinical Trials
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Premier Clinical Research Group
Toms River, New Jersey, United States, 08755
United States, New York
SUNY Upstate Syracuse, Department of Pediatrics
Syracuse, New York, United States, 13210
Hartrich Aquino & Hrab, PC
Williamsville, New York, United States, 14221
United States, North Carolina
Western Wake Pediatrics
Cary, North Carolina, United States, 27518
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Duke Pediatric Clinical Research Program
Durham, North Carolina, United States, 27710
North Carolina Children's and Adults Clinical Research Foundation
Sylva, North Carolina, United States, 28779
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Center for Clinical and Translational Research
Columbus, Ohio, United States, 43205
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73069
The University of Oklahoma
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Northwest Pediatric Kidney Specialists, LLC
Portland, Oregon, United States, 97227
Oregon Health and Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
South East Texas Cardiology Associates
Beaumont, Texas, United States, 77701
University of Texas Medical Center
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Huguenot Pediatrics
Midlothian, Virginia, United States, 23113
Children's Specialty Group
Norfolk, Virginia, United States, 23510
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital de Niños "Dr. Ricardo Gutiérrez"
Buenos Aires, Argentina
Hospital Interzonal Especializado Materno Infantil
Buenos Aires, Argentina
Hospital General Interzonal "Dr. José Penna"
Buenos Aires, Argentina
Hospital de Niños Juan Carlos Navarro
San Juan, Argentina
Centro Infantil del Rínon
Tucomán, Argentina
Chile
Clínica Las Condes
Santiago, Chile
Hospital de Niños Roberto del Rio
Santiago, Chile
Hospital Luis Calvo Mackena
Santiago, Chile
Hospital Dr. Gustavo Fricke
Vina del Mar, Chile
Colombia
Fundación Bios
Barranquilla, Colombia
Instituto Nacional del Riñón
Bogotá, Colombia
Hospital de San Jose
Bogotá, Colombia
Fundación Cardio Infantil - Instituto de Cardiología
Bogotá, Colombia
Hospital Pablo Tobon Uribe
Medellin, Colombia
Hospital Universitario San Vicente de Paul
Medellin, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
India
Gujarat Kidney Foundation, Jivraj Mehta Hospital
Ahmedabad, India
Heart Care Clinic
Ahmedabad, India
St. John's Hospital
Bangalore, India
Institute of Child Health & Hospital for Children
Chennai, India
AIl India Institute medical sciences
Delhi, India
Apollo Hospital
Delhi, India
Maulana Azad Medical College and Lok Nayak Hospital
Delhi, India
Apollo Hospital Hyderabad
Hyderabaad, India
Nizam's Institute of Medical Sciences
Hyderabaad, India
Christian Medical College and Hospital
Ludhiana, India
Jaslok Hospital and Research Centre
Mumbai, India
KEM Hospital Research Centre
Pune, India
Kerala Institute of Medical Science
Trivandrum, India
Poland
Klinika Nefrologii Dzieciecej SPSK nr 1 ACK AMG
Gdansk, Poland
Katedra i Klinika Kardiologii Dzieciecej SK nr 6, Gornoslaskie Centrum Zdrowia Dziecka i Matki, Slaska AM
Katowice, Poland
II Katedra Pediatrii, Klinika Kardiologii Dzieciecej UM w Lodzi
Lodz, Poland
Klinika Nefrologii i Dializoterapii, Instytut Centrum Zdrowia Matki Polki
Lodz, Poland
Klinika Kardiologii i Nefrologii Dzieciecej AM
Poznan, Poland
I Klinika Chorob Dzieci SPSK nr 1 PAM
Szczecin, Poland
Oddzial Nefrologi Dzieciecej ze Stacja Dializ SSP ZOZ nad Dziecklem i Mlodzieza
Szczecin, Poland
Oddzial Pediatrii i Nefrologii ze Stacja Dializ, Wojewodzki Szpital Dzieciecy
Torun, Poland
Klinika Nefrologii i Transplantacji Nerek, Instytut Pomnik Centrum Zdrowia Dziecka
Warszawa, Poland
Klinika Nefrologii Pediatrycznej AM
Wroclaw, Poland
South Africa
Benmed Park Clinic
Benoni, South Africa
Chris Hani Baragwanath
Johannesburg, South Africa
Global Clinical Trial Centre
Port Elizabeth, South Africa
Potchefstroom Medi-Clinic
Potchefstroom, South Africa
Eastmed Medical centre
Pretoria, South Africa
Jubilee CTC Jubilee Hospital
Pretoria, South Africa
Pretoria Academic Hospital
Pretoria, South Africa
Zuid Afrikaans Hospital
Pretoria, South Africa
Sandton Clinical Research Centre
Sandton, South Africa
Turkey
Istanbul University Istanbul Medical Faculty Pediatric Nephrology
Istanbul, Turkey
Marmara University Medical Faculty Pediatric Nephrology
Istanbul, Turkey
Dokuzeylul University Medical Faculty Pediatric Nephrology
Izmir, Turkey
Ondokummayis University Medical Faculty Pediatric Nephrology
Samsun, Turkey
Ukraine
Dnepropetrovsk Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital
Dnepropetrovsk, Ukraine
Kharkov State University,Dept. of hospital pediatric on the bases of Regional Children's Hospital
Kharkov, Ukraine
NMU n.b. Bogomolets, on b.o. Chil. Clin.Hosp.#2, Department of Pediatrics #2
Kiev, Ukraine
Institute of Pediatrics and Obstetrics AMS of Ukraine, Department of ecology related health problems
Kyiv, Ukraine
Danylo Halytskiy Lviv NationalMedical University, Department of Faculty
Lviv, Ukraine
Odessa State Medical University, Dept. of hospital pediatric and neonotology on the bases of Regional Children Hospital
Odessa, Ukraine
Crim.St. Med. Uni. On b.o. Rep. Child.Clin.Hosp. Chair of Pediat. W.c. of Physioth. Of the Postgr.dept
Simferopol, Ukraine
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
Vinnitsa National Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital
Vinnitsa, Ukraine
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00389519     History of Changes
Other Study ID Numbers: K726-06-4003
Study First Received: October 17, 2006
Results First Received: January 21, 2010
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
India: Ministry of Health
Poland: Ministry of Health
South Africa: Medicines Control Council
Turkey: Ministry of Health
Ukraine: Ministry of Health

Keywords provided by Pfizer:
Hypertension/*etiology
Blood Pressure
Pediatric
Adolescent
Child

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014