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ClinicalTrials.gov public records Last synced Oct 4, 2026, 5:11 AM EDT

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Showing 1–24 of 61 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: tetrahydrobiopterin (BH4) Clear all
Completed Not applicable Interventional Results available

Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.

NCT01135186
View directory record Official record
Conditions
Gastroparesis
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
Stanford University
Other
Eligibility
18 Years to 65 Years · Female only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Sep 10, 2019 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 1 Interventional

6R-BH4 Pulmonary Arterial Hypertension Study

NCT00435331
View directory record Official record
Conditions
Pulmonary Arterial Hypertension
Interventions
sapropterin dihydrochloride (6R-BH4)
Drug
Lead sponsor
Vanderbilt University
Other
Eligibility
18 Years and older
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jun 19, 2013 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of Kuvan Treatment in Adults With GTPCH Deficiency

NCT01425528
View directory record Official record
Conditions
GTP Cyclohydrolase Deficiency
Interventions
Sapropterin
Drug
Lead sponsor
University of Utah
Other
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 1, 2025 · Synced Oct 4, 2026, 5:11 AM EDT
Withdrawn Not applicable Interventional

Neuroimaging and Neurocognitive Assessment and Response to Sapropterin Dihydrochloride Treatment in Phenylketonuria

NCT01412437
View directory record Official record
Conditions
PKU
Interventions
diet, sapropterin dihydrochloride
Dietary Supplement · Drug
Lead sponsor
Children's National Research Institute
Other
Eligibility
18 Years to 40 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated Dec 17, 2014 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 3 Interventional Results available

Study of Phenoptin to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet

NCT00272792
View directory record Official record
Conditions
Phenylketonurias
Interventions
Sapropterin Dihydrochloride, Placebo
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
4 Years to 12 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
9
States / cities
Los Angeles, California • Oakland, California • Sacramento, California + 6 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2015 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 2 Interventional

Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria

NCT00104260
View directory record Official record
Conditions
Phenylketonurias
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
8 Years and older
Enrollment
700 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
13
States / cities
Los Angeles, California • Oakland, California • New Haven, Connecticut + 10 more
Source: ClinicalTrials.gov public record
Updated Apr 9, 2007 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 2 Interventional Results available

Endothelial Facilitation in Alzheimer's Disease

NCT01439555
View directory record Official record
Conditions
Alzheimer's Disease
Interventions
Simvastatin, L-Arginine, Tetrahydrobiopterin
Drug
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
55 Years to 85 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 30, 2019 · Synced Oct 4, 2026, 5:11 AM EDT
Completed No phase listed Observational

Study to Evaluate the Effects of Kuvan on Individuals With Phenylketonuria (PKU) With Maladaptive Behaviors

NCT00728676
View directory record Official record
Conditions
Phenylketonuria
Interventions
Not listed
Lead sponsor
Shoji Yano
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jan 18, 2013 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 3 Interventional Results available

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

NCT00104247
View directory record Official record
Conditions
Phenylketonurias
Interventions
sapropterin dihydrochloride, 6R-BH4, tetrahydrobiopterin
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
8 Years and older
Enrollment
89 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
13
States / cities
Los Angeles, California • Oakland, California • New Haven, Connecticut + 10 more
Source: ClinicalTrials.gov public record
Updated Jul 23, 2014 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 4 Interventional Results available

Effects of Kuvan on Melatonin Secretion

NCT01617070
View directory record Official record
Conditions
Phenylketonuria (PKU)
Interventions
Kuvan, Large Neutral Amino Acid Therapy
Drug · Dietary Supplement
Lead sponsor
University of Southern California
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Nov 18, 2016 · Synced Oct 4, 2026, 5:11 AM EDT
Terminated No phase listed Observational

Behavioral Effects of Kuvan in Children With Mild Phenylketonuria

NCT00827762
View directory record Official record
Conditions
Phenylketonuria
Interventions
Kuvan
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
6 Years to 18 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
4
States / cities
Chicago, Illinois • Columbia, Missouri • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Dec 5, 2013 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Cystic Fibrosis and Endothelial Function: At Rest and During Exercise

NCT01772758
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
BH4 5mg, BH4 20mg, Antioxidant Cocktail
Drug · Dietary Supplement
Lead sponsor
Augusta University
Other
Eligibility
7 Years and older
Enrollment
64 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2016
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Jun 20, 2019 · Synced Oct 4, 2026, 5:11 AM EDT
Terminated Not applicable Interventional Accepts healthy volunteers Results available

Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy

NCT01541397
View directory record Official record
Conditions
Hyperphenylalaninemia, Phenylketonuria
Interventions
Sapropterin
Drug
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
18 Years to 50 Years
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 7, 2015 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Not applicable Interventional Results available

Fluorodeoxyglucose Positron Emission Tomography (FDG PET) Findings in Patients With Phenylketonuria Before and After KUVAN Therapy

NCT00986973
View directory record Official record
Conditions
Phenylketonuria
Interventions
Sapropterin
Drug
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
18 Years to 50 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jun 8, 2015 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 2 Interventional Results available

A Phase 2 Study of the Effects of 6R-BH4 in Subjects With Sickle Cell Disease

NCT00445978
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Sapropterin Dihydrochloride
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
15 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
12
States / cities
Washington D.C., District of Columbia • Augusta, Georgia • Savannah, Georgia + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 25, 2021 · Synced Oct 4, 2026, 5:11 AM EDT
Withdrawn Phase 2Phase 3 Interventional

Trial of Kuvan in Lesch-Nyhan Disease

NCT00935753
View directory record Official record
Conditions
Behavioral Manifestations of Lesch-Nyhan Disease
Interventions
sapropterin
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
4 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Aug 2, 2019 · Synced Oct 4, 2026, 5:11 AM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

: Vascular Function in Health and Disease

NCT02966665
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease, Pulmonary Artery Hypertension, Heart Failure, Hypertension
Interventions
Maximum Exercise Tests, BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine, BQ-123, MitoQ, BH4
Other · Drug
Lead sponsor
D. Walter Wray
Other
Eligibility
18 Years and older
Enrollment
420 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2030
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Not applicable Interventional Results available

Rhode Island Diastolic Dysfunction - Heart Failure

NCT02353312
View directory record Official record
Conditions
Heart Failure, Cardiovascular Disease
Interventions
Kuvan
Drug
Lead sponsor
Providence VA Medical Center
Federal
Eligibility
18 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Jul 3, 2025 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 2 Interventional

A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension

NCT00325962
View directory record Official record
Conditions
Hypertension
Interventions
6R-BH4 (sapropterin dihydrochloride)
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
18 Years and older
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
24
States / cities
Hoover, Alabama • Huntsville, Alabama • Mobile, Alabama + 21 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2009 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 3 Interventional Results available

Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients

NCT01114737
View directory record Official record
Conditions
Phenylketonuria
Interventions
Sapropterin dihydrochloride, Placebo
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
8 Years to 65 Years
Enrollment
206 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
26
States / cities
La Jolla, California • Los Angeles, California • Palo Alto, California + 23 more
Source: ClinicalTrials.gov public record
Updated Feb 1, 2016 · Synced Oct 4, 2026, 5:11 AM EDT
Withdrawn Phase 2 Interventional

L-arginine Study for Persistent Symptoms of Schizophrenia

NCT04054973
View directory record Official record
Conditions
Schizo Affective Disorder, Schizophrenia
Interventions
L-arginine, Sapropterin Dihydrochloride
Drug
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jan 20, 2022 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects

NCT00789568
View directory record Official record
Conditions
Phenylketonuria
Interventions
sapropterin dihydrochloride, Moxifloxacin, Moxifloxacin placebo
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
18 Years to 50 Years
Enrollment
56 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2009
U.S. locations
1
States / cities
Fargo, North Dakota
Source: ClinicalTrials.gov public record
Updated Jul 23, 2021 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 2 Interventional Results available

Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria

NCT00625820
View directory record Official record
Conditions
Kidney Disease, Albuminuria
Interventions
6R BH4, Vitamin C
Drug · Dietary Supplement
Lead sponsor
University of Michigan
Other
Eligibility
18 Years to 75 Years
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Oct 18, 2016 · Synced Oct 4, 2026, 5:11 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Open-Label Extension Study of Kuvan for Autism

NCT00943579
View directory record Official record
Conditions
Autistic Disorder
Interventions
Kuvan®
Drug
Lead sponsor
The Children's Health Council
Other
Eligibility
3 Years to 6 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated May 2, 2018 · Synced Oct 4, 2026, 5:11 AM EDT