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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00389519
Other study ID # K726-06-4003
Secondary ID
Status Terminated
Phase Phase 3
First received October 17, 2006
Last updated June 6, 2012
Start date October 2006
Est. completion date November 2007

Study information

Verified date June 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: Ministry of HealthCanada: Health CanadaChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosIndia: Ministry of HealthPoland: Ministry of HealthSouth Africa: Medicines Control CouncilTurkey: Ministry of HealthUkraine: Ministry of Health
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 422
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 16 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ramipril
once a day oral ramipril capsules given for 4 weeks
placebo
once a day oral placebo capsule for 4 weeks

Locations

Country Name City State
Argentina 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
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
Colombia 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 Medellin
Colombia Hospital Universitario San Vicente de Paul Medellin
Colombia Hospital Pablo Tobon Uribe Medellín
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
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
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
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
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
United States Emory University Atlanta Georgia
United States Medical College of Georgia Augusta Georgia
United States South East Texas Cardiology Associates Beaumont Texas
United States Impact Clinical Research Beverly Hills California
United States Craig Spiegel, MD Bridgeton Missouri
United States Western Wake Pediatrics Cary North Carolina
United States University of North Carolina Chapel Hill North Carolina
United States University of Virginia Charlottesville Virginia
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Pediatrics in Brevard Cocoa Beach Florida
United States Center for Clinical and Translational Research Columbus Ohio
United States Duke Pediatric Clinical Research Program Durham North Carolina
United States Hawaii Pacific Health Honolulu Hawaii
United States University of Texas Medical Center Houston Texas
United States Holston Medical Group Kingsport Tennessee
United States Watson Clinic Center for Research, Inc. Lakeland Florida
United States Children's Heart Center Las Vegas Nevada
United States Impact Clinical Trials Las Vegas Nevada
United States UAMS College of Medicine/ Arkansas Children's Hospital Little Rock Arkansas
United States Woodland International Research Group, LLC Little Rock Arkansas
United States Neufeld Medical Group Los Angeles California
United States Kosair Children's Hospital Louisville Kentucky
United States Le Bonheur Children's Hospital Memphis Tennessee
United States Huguenot Pediatrics Midlothian Virginia
United States Children's Specialty Group Norfolk Virginia
United States Central Sooner Research Norman Oklahoma
United States Almon Clinical Research, Inc. Orange California
United States Nephrology and Hypertension Consultants Park Ridge Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Northwest Pediatric Kidney Specialists, LLC Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States University of Utah Salt Lake City Utah
United States Louisiana State University Shreveport Louisiana
United States North Carolina Children's and Adults Clinical Research Foundation Sylva North Carolina
United States SUNY Upstate Syracuse, Department of Pediatrics Syracuse New York
United States Tinley Park Pediatric Associates Tinley Park Illinois
United States Premier Clinical Research Group Toms River New Jersey
United States The University of Oklahoma Tulsa Oklahoma
United States Hartrich Aquino & Hrab, PC Williamsville New York

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Colombia,  India,  Poland,  South Africa,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo Baseline to 4 weeks No
Secondary Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo Baseline to 4 weeks No
Secondary Change From Baseline to 4 Weeks in Serum Creatinine Value at end of treatment (up to 4 weeks) minus value at baseline Baseline up to 4 weeks Yes
Secondary Change From Baseline to 4 Weeks in Serum Potassium Value at end of treatment (up to 4 weeks) minus value at baseline Baseline up to 4 weeks Yes
Secondary Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR) Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function. Baseline up to 4 weeks Yes
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