A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
- Registration Number
- NCT00389519
- Lead Sponsor
- Pfizer
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 422
- 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.
- The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.
- The subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.
- 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.
- 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.
- Bilateral renal artery stenosis.
- Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmHg.
- Severe hypertension.
- Renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.
- Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.
- 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.
- 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.
- History of pancreatitis (active or inactive).
- Known sensitivity to angiotensin converting enzyme inhibitors or a history of angioneurotic edema.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo once per day ramipril low dose ramipril 0.3125, 0.625, or 1.25 mg once a day, based on subject weight ramipril mid dose ramipril 1.25, 2.5, or 5 mg once a day, based on subject weight ramipril high dose ramipril 5, 10, or 20 mg once a day, based on subject weight
- Primary Outcome Measures
Name Time Method Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure Baseline to 4 weeks Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
- Secondary Outcome Measures
Name Time Method Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure Baseline to 4 weeks 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 Baseline up to 4 weeks Value at end of treatment (up to 4 weeks) minus value at baseline
Change From Baseline to 4 Weeks in Serum Potassium Baseline up to 4 weeks 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) Baseline up to 4 weeks Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.
Trial Locations
- Locations (100)
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, 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
Premier Clinical Research Group
🇺🇸Toms River, New Jersey, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Hospital Dr. Gustavo Fricke
🇨🇱Vina del Mar, Chile
Heart Care Clinic
🇮🇳Ahmedabad, India
Klinika Nefrologii Dzieciecej SPSK nr 1 ACK AMG
🇵🇱Gdansk, Poland
Oddzial Pediatrii i Nefrologii ze Stacja Dializ, Wojewodzki Szpital Dzieciecy
🇵🇱Torun, Poland
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
Neufeld Medical Group
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Western Wake Pediatrics
🇺🇸Cary, North Carolina, United States
Center for Clinical and Translational Research
🇺🇸Columbus, Ohio, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Hawaii Pacific Health
🇺🇸Honolulu, Hawaii, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Children's Heart Center
🇺🇸Las Vegas, Nevada, United States
Duke Pediatric Clinical Research Program
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Texas Medical Center
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Hartrich Aquino & Hrab, PC
🇺🇸Williamsville, New York, United States
Global Clinical Trial Centre
🇿🇦Port Elizabeth, South Africa
Sandton Clinical Research Centre
🇿🇦Sandton, South Africa
Klinika Nefrologii Pediatrycznej AM
🇵🇱Wroclaw, Poland
Potchefstroom Medi-Clinic
🇿🇦Potchefstroom, South Africa
Benmed Park Clinic
🇿🇦Benoni, South Africa
Chris Hani Baragwanath
🇿🇦Johannesburg, South Africa
Eastmed Medical centre
🇿🇦Pretoria, South Africa
Marmara University Medical Faculty Pediatric Nephrology
🇹🇷Istanbul, Turkey
Dokuzeylul University Medical Faculty Pediatric Nephrology
🇹🇷Izmir, Turkey
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
Vinnitsa National Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital
🇺🇦Vinnitsa, Ukraine
Zuid Afrikaans Hospital
🇿🇦Pretoria, South Africa
Pretoria Academic Hospital
🇿🇦Pretoria, South Africa
Jubilee CTC Jubilee Hospital
🇿🇦Pretoria, South Africa
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
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
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Tinley Park Pediatric Associates
🇺🇸Tinley Park, Illinois, United States
Nephrology and Hypertension Consultants
🇺🇸Park Ridge, 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
SUNY Upstate Syracuse, Department of Pediatrics
🇺🇸Syracuse, New York, United States
North Carolina Children's and Adults Clinical Research Foundation
🇺🇸Sylva, North Carolina, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The University of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Northwest Pediatric Kidney Specialists, LLC
🇺🇸Portland, Oregon, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
South East Texas Cardiology Associates
🇺🇸Beaumont, Texas, United States
Huguenot Pediatrics
🇺🇸Midlothian, Virginia, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Children's Specialty Group
🇺🇸Norfolk, Virginia, United States
Centro Infantil del RÃnon
🇦🇷Tucomán, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Hospital de Niños Juan Carlos Navarro
🇦🇷San Juan, Argentina
ClÃnica Las Condes
🇨🇱Santiago, Chile
Hospital Luis Calvo Mackena
🇨🇱Santiago, Chile
Fundación Bios
🇨🇴Barranquilla, Colombia
Hospital de Niños Roberto del Rio
🇨🇱Santiago, Chile
Instituto Nacional del Riñón
🇨🇴Bogotá, Colombia
Gujarat Kidney Foundation, Jivraj Mehta Hospital
🇮🇳Ahmedabad, India
Hospital de San Jose
🇨🇴Bogotá, Colombia
Fundación Cardio Infantil - Instituto de CardiologÃa
🇨🇴Bogotá, Colombia
KEM Hospital Research Centre
🇮🇳Pune, India
Hospital Pablo Tobon Uribe
🇨🇴MedellÃn, Colombia
Hospital Universitario San Vicente de Paul
🇨🇴Medellin, Colombia
St. John's Hospital
🇮🇳Bangalore, India
Apollo Hospital
🇮🇳Delhi, India
Institute of Child Health & Hospital for Children
🇮🇳Chennai, India
Maulana Azad Medical College and Lok Nayak Hospital
🇮🇳Delhi, India
AIl India Institute medical sciences
🇮🇳Delhi, India
Apollo Hospital Hyderabad
🇮🇳Hyderabaad, India
Christian Medical College and Hospital
🇮🇳Ludhiana, India
Nizam's Institute of Medical Sciences
🇮🇳Hyderabaad, India
Jaslok Hospital and Research Centre
🇮🇳Mumbai, India
Kerala Institute of Medical Science
🇮🇳Trivandrum, India
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
Oddzial Nefrologi Dzieciecej ze Stacja Dializ SSP ZOZ nad Dziecklem i Mlodzieza
🇵🇱Szczecin, Poland
Klinika Kardiologii i Nefrologii Dzieciecej AM
🇵🇱Poznan, Poland
I Klinika Chorob Dzieci SPSK nr 1 PAM
🇵🇱Szczecin, Poland
Kharkov State University,Dept. of hospital pediatric on the bases of Regional Children's Hospital
🇺🇦Kharkov, Ukraine
Institute of Pediatrics and Obstetrics AMS of Ukraine, Department of ecology related health problems
🇺🇦Kyiv, Ukraine
Istanbul University Istanbul Medical Faculty Pediatric Nephrology
🇹🇷Istanbul, Turkey
Klinika Nefrologii i Transplantacji Nerek, Instytut Pomnik Centrum Zdrowia Dziecka
🇵🇱Warszawa, Poland
Dnepropetrovsk Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital
🇺🇦Dnepropetrovsk, Ukraine
Ondokummayis University Medical Faculty Pediatric Nephrology
🇹🇷Samsun, Turkey
NMU n.b. Bogomolets, on b.o. Chil. Clin.Hosp.#2, Department of Pediatrics #2
🇺🇦Kiev, Ukraine