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NCT00838435 · ClinicalTrials.gov registry record · Phase 3

Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU

A Phase 3 study of Phenylketonuria, sponsored by BioMarin Pharmaceutical.

Completed
Registry status
Phase 3
Development phase
95
Enrollment target
19
Study locations

NCT00838435 is a Phase 3 study of Phenylketonuria that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 95 participants, roughly in line with the 91-participant average among 12 other Phenylketonuria trials with a reported enrollment target. The trial reports 19 study locations across 15 states.

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The verdict

NCT00838435, a Phase 3 study of Phenylketonuria, has completed, sponsored by BioMarin Pharmaceutical.

COMPLETED
Registry status
Phase 3
Development phase
95 participants
Enrollment target
19
Study locations

Study Summary

This multicenter, open label study is designed to evaluate the safety of Kuvan® and its effect on neurocognitive function, blood Phe concentration, and growth in children with PKU who are 0-6 years old.

Conditions Studied

Phenylketonuria

Interventions

  • DRUG sapropterin dihydrochloride

Study Locations (19)

California

  • - La Jolla
  • - Orange

Ohio

  • - Cleveland
  • - Columbus

Ontario

  • - Hamilton
  • - Toronto

Quebec

  • - Montreal
  • - Sainte-Foy

Florida

  • - Tampa

Illinois

  • - Chicago

Massachusetts

  • - Boston

Missouri

  • - Kansas City

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2009-02
Est. Completion 2018-09-14
Phase Phase 3

Sponsor

BioMarin Pharmaceutical

80 total trials

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What the Registry Record Tells You About NCT00838435

The ClinicalTrials.gov registry entry for NCT00838435 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 91-participant average among 12 other Phenylketonuria trials with a reported enrollment target. The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Phenylketonuria appearing as the primary indexed condition, and to 1 intervention - of which sapropterin dihydrochloride is the first listed.

NCT00838435 reports 19 study locations spanning 15 distinct geographic areas - top geographies include California, Ohio, Ontario.

Frequently Asked Questions

What is clinical trial NCT00838435 about?

NCT00838435 is a clinical study titled "Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU". This multicenter, open label study is designed to evaluate the safety of Kuvan® and its effect on neurocognitive function, blood Phe concentration, and growth in children with PKU who are 0-6 years old.

What is the current status of trial NCT00838435?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2009-02. Estimated completion is 2018-09-14.

What conditions does trial NCT00838435 study?

This clinical trial studies the following conditions: Phenylketonuria.

What interventions are being tested in trial NCT00838435?

The interventions under investigation include: sapropterin dihydrochloride (DRUG).

Who is sponsoring clinical trial NCT00838435?

This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00838435 being conducted?

This trial has 19 study locations across California, Florida, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.