A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
NCT ID: NCT00389519
Last Updated: 2012-06-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
422 participants
INTERVENTIONAL
2006-10-31
2007-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
once per day
placebo
once a day oral placebo capsule for 4 weeks
ramipril low dose
0.3125, 0.625, or 1.25 mg once a day, based on subject weight
ramipril
once a day oral ramipril capsules given for 4 weeks
ramipril mid dose
1.25, 2.5, or 5 mg once a day, based on subject weight
ramipril
once a day oral ramipril capsules given for 4 weeks
ramipril high dose
5, 10, or 20 mg once a day, based on subject weight
ramipril
once a day oral ramipril capsules given for 4 weeks
Interventions
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ramipril
once a day oral ramipril capsules given for 4 weeks
placebo
once a day oral placebo capsule for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
16 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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UAMS College of Medicine/ Arkansas Children's Hospital
Little Rock, Arkansas, United States
Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Impact Clinical Research
Beverly Hills, California, United States
Neufeld Medical Group
Los Angeles, California, United States
Almon Clinical Research, Inc.
Orange, California, United States
Pediatrics in Brevard
Cocoa Beach, Florida, United States
Watson Clinic Center for Research, Inc.
Lakeland, Florida, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Hawaii Pacific Health
Honolulu, Hawaii, United States
Nephrology and Hypertension Consultants
Park Ridge, Illinois, United States
Tinley Park Pediatric Associates
Tinley Park, Illinois, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Louisiana State University
Shreveport, Louisiana, United States
Craig Spiegel, MD
Bridgeton, Missouri, United States
Impact Clinical Trials
Las Vegas, Nevada, United States
Children's Heart Center
Las Vegas, Nevada, United States
Premier Clinical Research Group
Toms River, New Jersey, United States
SUNY Upstate Syracuse, Department of Pediatrics
Syracuse, New York, United States
Hartrich Aquino & Hrab, PC
Williamsville, New York, United States
Western Wake Pediatrics
Cary, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke Pediatric Clinical Research Program
Durham, North Carolina, United States
North Carolina Children's and Adults Clinical Research Foundation
Sylva, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Center for Clinical and Translational Research
Columbus, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
The University of Oklahoma
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Northwest Pediatric Kidney Specialists, LLC
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Holston Medical Group
Kingsport, Tennessee, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
South East Texas Cardiology Associates
Beaumont, Texas, United States
University of Texas Medical Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Huguenot Pediatrics
Midlothian, Virginia, United States
Children's Specialty Group
Norfolk, Virginia, United States
Hospital de Niños "Dr. Ricardo Gutiérrez"
Buenos Aires, , Argentina
Hospital General Interzonal "Dr. José Penna"
Buenos Aires, , Argentina
Hospital Interzonal Especializado Materno Infantil
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Hospital de Niños Juan Carlos Navarro
San Juan, , Argentina
Centro Infantil del Rínon
Tucomán, , Argentina
Clínica Las Condes
Santiago, , Chile
Hospital de Niños Roberto del Rio
Santiago, , Chile
Hospital Luis Calvo Mackena
Santiago, , Chile
Hospital Dr. Gustavo Fricke
Viña del Mar, , Chile
Fundación Bios
Barranquilla, , Colombia
Fundación Cardio Infantil - Instituto de Cardiología
Bogotá, , Colombia
Hospital de San Jose
Bogotá, , Colombia
Instituto Nacional del Riñón
Bogotá, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Hospital Universitario San Vicente de Paul
Medellín, , Colombia
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
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
Warsaw, , Poland
Klinika Nefrologii Pediatrycznej AM
Wroclaw, , Poland
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
Istanbul University Istanbul Medical Faculty Pediatric Nephrology
Istanbul, , Turkey (Türkiye)
Marmara University Medical Faculty Pediatric Nephrology
Istanbul, , Turkey (Türkiye)
Dokuzeylul University Medical Faculty Pediatric Nephrology
Izmir, , Turkey (Türkiye)
Ondokummayis University Medical Faculty Pediatric Nephrology
Samsun, , Turkey (Türkiye)
Dnepropetrovsk Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital
Dnipro, , Ukraine
Kharkov State University,Dept. of hospital pediatric on the bases of Regional Children's Hospital
Kharkiv, , 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
Odesa, , 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.
Uzhhorod, , Ukraine
Vinnitsa National Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital
Vinnitsa, , Ukraine
Countries
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Other Identifiers
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K726-06-4003
Identifier Type: -
Identifier Source: org_study_id
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