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CompletedNCT00997984

Safety study of extended-release guanfacine hydrochloride in ADHD

This study is completed in the United States and in Canada. It is testing extended-release guanfacine hydrochloride for ADHD.

ADHDDrugFrom 6 Years to 12 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether extended-release guanfacine hydrochloride (SPD503) may be useful for children experiencing ADHD.

What would participation involve?

Participants may receive extended-release guanfacine hydrochloride (SPD503), attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Canada and in the United States.

Who is it mainly for?

This study appears to be mainly for children with ADHD. Because it involves minors, a parent or guardian may need to be involved.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)

  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: November 17, 2009
Recruitment status
Completed
Enrollment listed in the registry
340
Sponsor
Shire
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Canada
Age range
From 6 Years to 12 Years
Official registry ID
NCT00997984
Official title
A Phase 3, Double-blind, Randomized, Multicenter, Placebo-controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children Aged 6-12 With a Diagnosis of Attention-Deficit/Hyperactivity Disorder

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Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Canada · 4 sites
  • BC Women;s Hospital and Health Centre
    Vancouver, British Columbia
    Site status: Not listed — confirm with the team
  • Toronto ADHD Clinic
    Toronto, Ontario
    Site status: Not listed — confirm with the team
  • ADHD Clinical/ The Kids Clinic
    Whitby, Ontario
    Site status: Not listed — confirm with the team
  • Royal University Hospital
    Saskatoon, Saskatchewan
    Site status: Not listed — confirm with the team
United States · 42 sites
  • Clinical Study Centers, LLC
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Valley Clinical Research, Inc.
    El Centro, California
    Site status: Not listed — confirm with the team
  • Peninsula Research Associates, Inc.
    Rolling Hills Estates, California
    Site status: Not listed — confirm with the team
  • Psychiatric centers at San Diego, Feighner Research
    San Diego, California
    Site status: Not listed — confirm with the team
  • Elite Clinical Trials, Inc.
    Wildomar, California
    Site status: Not listed — confirm with the team
  • Florida Clinical Research Center, LLC
    Bradenton, Florida
    Site status: Not listed — confirm with the team
  • Sarkis Clinical Trials
    Gainesville, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • Florida Clinical Research Center, LLC
    Maitland, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Janus Centerfor Psychiatric Research
    West Palm Beach, Florida
    Site status: Not listed — confirm with the team
  • Atlanta Center for Medical Research
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Northwest Clincial Research Group
    Marietta, Georgia
    Site status: Not listed — confirm with the team
  • Mountain West Clinical Trials
    Boise, Idaho
    Site status: Not listed — confirm with the team
  • University of Illinois Chicago
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • American Medical research, Inc.
    Oak Brook, Illinois
    Site status: Not listed — confirm with the team
  • Goldpoint Clinical Research, LLC
    Indianapolis, Indiana
    Site status: Not listed — confirm with the team
  • Clinco
    Terre Haute, Indiana
    Site status: Not listed — confirm with the team
  • Psychiatric Associates
    Overland Park, Kansas
    Site status: Not listed — confirm with the team
  • Vince and Associates Clinical Research
    Overland Park, Kansas
    Site status: Not listed — confirm with the team
  • Four Rivers Clinical Research, Inc.
    Paducah, Kentucky
    Site status: Not listed — confirm with the team
  • Louisiana Research Associates, Inc.
    New Orleans, Louisiana
    Site status: Not listed — confirm with the team
  • Marc Hertzman, M.D., P.C.
    Rockville, Maryland
    Site status: Not listed — confirm with the team
  • Richester Center for Behavioral Medicine
    Rochester Hills, Michigan
    Site status: Not listed — confirm with the team
  • Midwest research Group
    Saint Charles, Missouri
    Site status: Not listed — confirm with the team
  • Center for Psychiatry and Behavioral Medicine, Inc.
    Las Vegas, Nevada
    Site status: Not listed — confirm with the team
  • Children's Specialized Hospital
    Toms River, New Jersey
    Site status: Not listed — confirm with the team
  • Innovis Health
    Fargo, North Dakota
    Site status: Not listed — confirm with the team
  • IPS Research Company
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • CRI Worldwide, LLC
    Philadelphia, Pennsylvania
    Site status: Not listed — confirm with the team
  • Western Psychiatric Institute and Clinic
    Pittsburgh, Pennsylvania
    Site status: Not listed — confirm with the team
  • Rhode Island Hospital
    Providence, Rhode Island
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Memphis, Tennessee
    Site status: Not listed — confirm with the team
  • FutureSearch Clinical Trials
    Austin, Texas
    Site status: Not listed — confirm with the team
  • Claghorn-Lesem research Clinic
    Houston, Texas
    Site status: Not listed — confirm with the team
  • R/D Clinical Research, Inc.
    Lake Jackson, Texas
    Site status: Not listed — confirm with the team
  • Western Clinical Investigations
    Lubbock, Texas
    Site status: Not listed — confirm with the team
  • Cerebral Research, LLC
    San Antonio, Texas
    Site status: Not listed — confirm with the team
  • Vermont Clinical Study Center
    Burlington, Vermont
    Site status: Not listed — confirm with the team
  • NeuroScience Inc
    Herndon, Virginia
    Site status: Not listed — confirm with the team
  • Alliance Research Group, LLC
    Richmond, Virginia
    Site status: Not listed — confirm with the team
  • Northwest Clinical Research Center
    Bellevue, Washington
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with adhd. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving extended-release guanfacine hydrochloride (SPD503), placebo, extended-release guanfacine hydrochloride. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with adhd; age range: From 6 Years to 12 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Shire, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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