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

NCT00389519 | Terminated Phase 3 Results

• 1 other identifier: K726-06-4003
• Study Type: interventional
• Target: 422
• Locations: 9 countries
• Sites: 100

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.

Conditions

Hypertension

Keywords

Hypertension/*etiology; Blood Pressure; Pediatric; Adolescent; Child

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure

  Baseline to 4 weeks

• Change From Baseline to 4 Weeks in Serum Creatinine

  Baseline up to 4 weeks

• Change From Baseline to 4 Weeks in Serum Potassium

  Baseline up to 4 weeks

• Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)

  Baseline up to 4 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

once per day

Drug: placebo

ramipril low dose

EXPERIMENTAL

0.3125, 0.625, or 1.25 mg once a day, based on subject weight

Drug: ramipril

ramipril mid dose

EXPERIMENTAL

1.25, 2.5, or 5 mg once a day, based on subject weight

Drug: ramipril

ramipril high dose

EXPERIMENTAL

5, 10, or 20 mg once a day, based on subject weight

Drug: ramipril

Interventions

ramipril DRUG

once a day oral ramipril capsules given for 4 weeks

Also known as: Altace

ramipril high dose; ramipril low dose; ramipril mid dose

placebo DRUG

once a day oral placebo capsule for 4 weeks

Placebo

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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• The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (100)

UAMS College of Medicine/ Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Woodland International Research Group, LLC

Little Rock, Arkansas, 72211, United States

Location

Impact Clinical Research

Beverly Hills, California, 90211, United States

Location

Neufeld Medical Group

Los Angeles, California, 90048, United States

Location

Almon Clinical Research, Inc.

Orange, California, 92868, United States

Location

Pediatrics in Brevard

Cocoa Beach, Florida, 33155, United States

Location

Watson Clinic Center for Research, Inc.

Lakeland, Florida, 33805, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Hawaii Pacific Health

Honolulu, Hawaii, 96813, United States

Location

Nephrology and Hypertension Consultants

Park Ridge, Illinois, 60068, United States

Location

Tinley Park Pediatric Associates

Tinley Park, Illinois, 60477, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Louisiana State University

Shreveport, Louisiana, 71103, United States

Location

Craig Spiegel, MD

Bridgeton, Missouri, 63044, United States

Location

Impact Clinical Trials

Las Vegas, Nevada, 89106, United States

Location

Children's Heart Center

Las Vegas, Nevada, 89109, United States

Location

Premier Clinical Research Group

Toms River, New Jersey, 08755, United States

Location

SUNY Upstate Syracuse, Department of Pediatrics

Syracuse, New York, 13210, United States

Location

Hartrich Aquino & Hrab, PC

Williamsville, New York, 14221, United States

Location

Western Wake Pediatrics

Cary, North Carolina, 27518, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Duke Pediatric Clinical Research Program

Durham, North Carolina, 27710, United States

Location

North Carolina Children's and Adults Clinical Research Foundation

Sylva, North Carolina, 28779, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Center for Clinical and Translational Research

Columbus, Ohio, 43205, United States

Location

Central Sooner Research

Norman, Oklahoma, 73069, United States

Location

The University of Oklahoma

Tulsa, Oklahoma, 74135, United States

Location

Oregon Health and Science University

Portland, Oregon, 97201, United States

Location

Northwest Pediatric Kidney Specialists, LLC

Portland, Oregon, 97227, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38105, United States

Location

South East Texas Cardiology Associates

Beaumont, Texas, 77701, United States

Location

University of Texas Medical Center

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Huguenot Pediatrics

Midlothian, Virginia, 23113, United States

Location

Children's Specialty Group

Norfolk, Virginia, 23510, United States

Location

Hospital de Niños "Dr. Ricardo Gutiérrez"

Buenos Aires, Argentina

Location

Hospital General Interzonal "Dr. José Penna"

Buenos Aires, Argentina

Location

Hospital Interzonal Especializado Materno Infantil

Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Hospital de Niños Juan Carlos Navarro

San Juan, Argentina

Location

Centro Infantil del Rínon

Tucomán, Argentina

Location

Clínica Las Condes

Santiago, Chile

Location

Hospital de Niños Roberto del Rio

Santiago, Chile

Location

Hospital Luis Calvo Mackena

Santiago, Chile

Location

Hospital Dr. Gustavo Fricke

Viña del Mar, Chile

Location

Fundación Bios

Barranquilla, Colombia

Location

Fundación Cardio Infantil - Instituto de Cardiología

Bogotá, Colombia

Location

Hospital de San Jose

Bogotá, Colombia

Location

Instituto Nacional del Riñón

Bogotá, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, Colombia

Location

Hospital Universitario San Vicente de Paul

Medellín, Colombia

Location

Gujarat Kidney Foundation, Jivraj Mehta Hospital

Ahmedabad, India

Location

Heart Care Clinic

Ahmedabad, India

Location

St. John's Hospital

Bangalore, India

Location

Institute of Child Health & Hospital for Children

Chennai, India

Location

AIl India Institute medical sciences

Delhi, India

Location

Apollo Hospital

Delhi, India

Location

Maulana Azad Medical College and Lok Nayak Hospital

Delhi, India

Location

Apollo Hospital Hyderabad

Hyderabaad, India

Location

Nizam's Institute of Medical Sciences

Hyderabaad, India

Location

Christian Medical College and Hospital

Ludhiana, India

Location

Jaslok Hospital and Research Centre

Mumbai, India

Location

KEM Hospital Research Centre

Pune, India

Location

Kerala Institute of Medical Science

Trivandrum, India

Location

Klinika Nefrologii Dzieciecej SPSK nr 1 ACK AMG

Gdansk, Poland

Location

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

Katowice, Poland

Location

II Katedra Pediatrii, Klinika Kardiologii Dzieciecej UM w Lodzi

Lodz, Poland

Location

Klinika Nefrologii i Dializoterapii, Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Location

Klinika Kardiologii i Nefrologii Dzieciecej AM

Poznan, Poland

Location

I Klinika Chorob Dzieci SPSK nr 1 PAM

Szczecin, Poland

Location

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

Szczecin, Poland

Location

Oddzial Pediatrii i Nefrologii ze Stacja Dializ, Wojewodzki Szpital Dzieciecy

Torun, Poland

Location

Klinika Nefrologii i Transplantacji Nerek, Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, Poland

Location

Klinika Nefrologii Pediatrycznej AM

Wroclaw, Poland

Location

Benmed Park Clinic

Benoni, South Africa

Location

Chris Hani Baragwanath

Johannesburg, South Africa

Location

Global Clinical Trial Centre

Port Elizabeth, South Africa

Location

Potchefstroom Medi-Clinic

Potchefstroom, South Africa

Location

Eastmed Medical centre

Pretoria, South Africa

Location

Jubilee CTC Jubilee Hospital

Pretoria, South Africa

Location

Pretoria Academic Hospital

Pretoria, South Africa

Location

Zuid Afrikaans Hospital

Pretoria, South Africa

Location

Sandton Clinical Research Centre

Sandton, South Africa

Location

Istanbul University Istanbul Medical Faculty Pediatric Nephrology

Istanbul, Turkey (Türkiye)

Location

Marmara University Medical Faculty Pediatric Nephrology

Istanbul, Turkey (Türkiye)

Location

Dokuzeylul University Medical Faculty Pediatric Nephrology

Izmir, Turkey (Türkiye)

Location

Ondokummayis University Medical Faculty Pediatric Nephrology

Samsun, Turkey (Türkiye)

Location

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

Dnipro, Ukraine

Location

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

Kharkiv, Ukraine

Location

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

Kiev, Ukraine

Location

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

Kyiv, Ukraine

Location

Danylo Halytskiy Lviv NationalMedical University, Department of Faculty

Lviv, Ukraine

Location

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

Odesa, Ukraine

Location

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

Simferopol, Ukraine

Location

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

Location

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

Vinnitsa, Ukraine

Location

MeSH Terms

Conditions

Hypertension

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Professional Information Services
• Organization: King Pharmaceuticals, Inc.

1-800-776-3637

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 19, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: June 11, 2012
• Results First Posted: May 19, 2010

Record last verified: 2012-06

Locations

CO (6); US (39); CL (4); AR (6); IN (13); TU (4); UA (9); ZA (9); PL (10)