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

> **NCT00838435** · PHASE3 · COMPLETED · sponsor: **BioMarin Pharmaceutical** · enrollment: 95 (actual)

## Conditions studied

- Phenylketonuria

## Interventions

- **DRUG:** sapropterin dihydrochloride

## Key facts

- **NCT ID:** NCT00838435
- **Lead sponsor:** BioMarin Pharmaceutical
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-02
- **Primary completion:** 2018-09-14
- **Final completion:** 2018-09-14
- **Target enrollment:** 95 (ACTUAL)
- **Last updated:** 2020-12-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00838435

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00838435, "Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT00838435. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*