Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU
Public ClinicalTrials.gov record NCT00838435. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3b Open-Label Study to Evaluate the Effect of Kuvan® on Neurocognitive Function, Maintenance of Blood Phenylalanine Concentrations, Safety, and Population Pharmacokinetics in Young Children With Phenylketonuria
Study identification
- NCT ID
- NCT00838435
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- BioMarin Pharmaceutical
- Industry
- Enrollment
- 95 participants
Conditions and interventions
Conditions
Interventions
- sapropterin dihydrochloride Drug
Drug
Eligibility (public fields only)
- Age range
- Up to 6 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2009
- Primary completion
- Sep 13, 2018
- Completion
- Sep 13, 2018
- Last update posted
- Dec 21, 2020
2009 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | La Jolla | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Hershey | Pennsylvania | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00838435, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2020 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00838435 live on ClinicalTrials.gov.