# Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels

> **NCT00104247** · PHASE3 · COMPLETED · sponsor: **BioMarin Pharmaceutical** · enrollment: 89 (actual)

## Conditions studied

- Phenylketonurias

## Interventions

- **DRUG:** sapropterin dihydrochloride, 6R-BH4, tetrahydrobiopterin

## Key facts

- **NCT ID:** NCT00104247
- **Lead sponsor:** BioMarin Pharmaceutical
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2005-03
- **Primary completion:** —
- **Final completion:** 2006-02
- **Target enrollment:** 89 (ACTUAL)
- **Last updated:** 2014-07-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00104247

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00104247, "Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels". Retrieved via AI Analytics 2026-07-04 from https://api.ai-analytics.org/clinical/NCT00104247. Licensed CC0.

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