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HypertensionPhase 3NCT00389519

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

A Phase 3 study testing ramipril in people with Hypertension, run by Pfizer at 100 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
Hypertension
What is being tested?
ramipril
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
422 participants
Where
100 sitesin 9 countries
Study dates
Oct 2006to Nov 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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  • The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

100 sites in 9 countries.

100 sites in 9 countries

United States39 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • South East Texas Cardiology Associates

    Beaumont, Texas, 77701

  • Impact Clinical Research

    Beverly Hills, California, 90211

  • Craig Spiegel, MD

    Bridgeton, Missouri, 63044

  • Western Wake Pediatrics

    Cary, North Carolina, 27518

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Pediatrics in Brevard

    Cocoa Beach, Florida, 33155

  • Center for Clinical and Translational Research

    Columbus, Ohio, 43205

  • Duke Pediatric Clinical Research Program

    Durham, North Carolina, 27710

  • Hawaii Pacific Health

    Honolulu, Hawaii, 96813

  • University of Texas Medical Center

    Houston, Texas, 77030

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Watson Clinic Center for Research, Inc.

    Lakeland, Florida, 33805

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • Children's Heart Center

    Las Vegas, Nevada, 89109

  • UAMS College of Medicine/ Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Woodland International Research Group, LLC

    Little Rock, Arkansas, 72211

  • Neufeld Medical Group

    Los Angeles, California, 90048

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38105

  • Huguenot Pediatrics

    Midlothian, Virginia, 23113

  • Children's Specialty Group

    Norfolk, Virginia, 23510

  • Central Sooner Research

    Norman, Oklahoma, 73069

  • Almon Clinical Research, Inc.

    Orange, California, 92868

  • Nephrology and Hypertension Consultants

    Park Ridge, Illinois, 60068

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Oregon Health and Science University

    Portland, Oregon, 97201

  • Northwest Pediatric Kidney Specialists, LLC

    Portland, Oregon, 97227

  • University of Utah

    Salt Lake City, Utah, 84108

  • Louisiana State University

    Shreveport, Louisiana, 71103

  • North Carolina Children's and Adults Clinical Research Foundation

    Sylva, North Carolina, 28779

  • SUNY Upstate Syracuse, Department of Pediatrics

    Syracuse, New York, 13210

  • Tinley Park Pediatric Associates

    Tinley Park, Illinois, 60477

  • Premier Clinical Research Group

    Toms River, New Jersey, 08755

  • The University of Oklahoma

    Tulsa, Oklahoma, 74135

  • Hartrich Aquino & Hrab, PC

    Williamsville, New York, 14221

Other trials in United States

India13 sites

  • Gujarat Kidney Foundation, Jivraj Mehta Hospital

    Ahmedabad

  • Heart Care Clinic

    Ahmedabad

  • St. John's Hospital

    Bangalore

  • Institute of Child Health & Hospital for Children

    Chennai

  • AIl India Institute medical sciences

    Delhi

  • Apollo Hospital

    Delhi

  • Maulana Azad Medical College and Lok Nayak Hospital

    Delhi

  • Apollo Hospital Hyderabad

    Hyderabaad

  • Nizam's Institute of Medical Sciences

    Hyderabaad

  • Christian Medical College and Hospital

    Ludhiana

  • Jaslok Hospital and Research Centre

    Mumbai

  • KEM Hospital Research Centre

    Pune

  • Kerala Institute of Medical Science

    Trivandrum

Other trials in India

Poland10 sites

  • Klinika Nefrologii Dzieciecej SPSK nr 1 ACK AMG

    Gdansk

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

    Katowice

  • II Katedra Pediatrii, Klinika Kardiologii Dzieciecej UM w Lodzi

    Lodz

  • Klinika Nefrologii i Dializoterapii, Instytut Centrum Zdrowia Matki Polki

    Lodz

  • Klinika Kardiologii i Nefrologii Dzieciecej AM

    Poznan

  • I Klinika Chorob Dzieci SPSK nr 1 PAM

    Szczecin

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

    Szczecin

  • Oddzial Pediatrii i Nefrologii ze Stacja Dializ, Wojewodzki Szpital Dzieciecy

    Torun

  • Klinika Nefrologii i Transplantacji Nerek, Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw

  • Klinika Nefrologii Pediatrycznej AM

    Wroclaw

Other trials in Poland

South Africa9 sites

  • Benmed Park Clinic

    Benoni

  • Chris Hani Baragwanath

    Johannesburg

  • Global Clinical Trial Centre

    Port Elizabeth

  • Potchefstroom Medi-Clinic

    Potchefstroom

  • Eastmed Medical centre

    Pretoria

  • Jubilee CTC Jubilee Hospital

    Pretoria

  • Pretoria Academic Hospital

    Pretoria

  • Zuid Afrikaans Hospital

    Pretoria

  • Sandton Clinical Research Centre

    Sandton

Other trials in South Africa

Ukraine9 sites

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

    Dnipro

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

    Kharkiv

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

    Kiev

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

    Kyiv

  • Danylo Halytskiy Lviv NationalMedical University, Department of Faculty

    Lviv

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

    Odesa

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

    Simferopol

  • 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

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

    Vinnitsa

Other trials in Ukraine

Argentina6 sites

  • Hospital de Niños "Dr. Ricardo Gutiérrez"

    Buenos Aires

  • Hospital General Interzonal "Dr. José Penna"

    Buenos Aires

  • Hospital Interzonal Especializado Materno Infantil

    Buenos Aires

  • Hospital Italiano de Buenos Aires

    Buenos Aires

  • Hospital de Niños Juan Carlos Navarro

    San Juan

  • Centro Infantil del Rínon

    Tucomán

Other trials in Argentina

Colombia6 sites

  • Fundación Bios

    Barranquilla

  • Fundación Cardio Infantil - Instituto de Cardiología

    Bogotá

  • Hospital de San Jose

    Bogotá

  • Instituto Nacional del Riñón

    Bogotá

  • Hospital Pablo Tobon Uribe

    Medellín

  • Hospital Universitario San Vicente de Paul

    Medellín

Other trials in Colombia

Chile4 sites

  • Clínica Las Condes

    Santiago

  • Hospital de Niños Roberto del Rio

    Santiago

  • Hospital Luis Calvo Mackena

    Santiago

  • Hospital Dr. Gustavo Fricke

    Viña del Mar

Other trials in Chile

Turkey (Türkiye)4 sites

  • Istanbul University Istanbul Medical Faculty Pediatric Nephrology

    Istanbul

  • Marmara University Medical Faculty Pediatric Nephrology

    Istanbul

  • Dokuzeylul University Medical Faculty Pediatric Nephrology

    Izmir

  • Ondokummayis University Medical Faculty Pediatric Nephrology

    Samsun

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions
Hypertension
Being tested
ramipril, placebo
Keywords
Hypertension/*etiology, Blood Pressure, Pediatric, Adolescent, Child
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ramiprilDrug

    Also called Altace

    once a day oral ramipril capsules given for 4 weeks

  • placeboDrug

    once a day oral placebo capsule for 4 weeks

Study groups in NCT00389519
Study groupRoleWhat they receive
PlaceboPlacebo comparatoronce per day
Receives: Drug: placebo
ramipril low doseExperimental0.3125, 0.625, or 1.25 mg once a day, based on subject weight
Receives: Drug: ramipril
ramipril mid doseExperimental1.25, 2.5, or 5 mg once a day, based on subject weight
Receives: Drug: ramipril
ramipril high doseExperimental5, 10, or 20 mg once a day, based on subject weight
Receives: Drug: ramipril

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to 4 weeks

Secondary outcomes (4)

  1. 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

    Measured: Baseline to 4 weeks

  2. Change From Baseline to 4 Weeks in Serum Creatinine

    Value at end of treatment (up to 4 weeks) minus value at baseline

    Measured: Baseline up to 4 weeks

  3. Change From Baseline to 4 Weeks in Serum Potassium

    Value at end of treatment (up to 4 weeks) minus value at baseline

    Measured: Baseline up to 4 weeks

  4. 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.

    Measured: Baseline up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionNov 2007
  4. Study completionNov 2007

Why it stopped: A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389519
Sponsor's protocol ID
K726-06-4003
Status last verified
Jun 2012
First submitted
17 Oct 2006
Last updated
11 Jun 2012

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ramipril in people with Hypertension, run by Pfizer at 100 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, India, Poland, South Africa, Ukraine and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.

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