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ClinicalTrials.gov public records Last synced Oct 2, 2026, 3:22 PM EDT

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Showing 25–48 of 55 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Sapropterin Dihydrochloride Clear all
Completed Phase 2 Interventional Results available

Sapropterin as a Treatment for Autistic Disorder

NCT00850070
View directory record Official record
Conditions
Autistic Disorder
Interventions
sapropterin, Placebo
Drug
Lead sponsor
The Children's Health Council
Other
Eligibility
3 Years to 6 Years
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated May 1, 2018 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers

Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

NCT02042196
View directory record Official record
Conditions
Menopause, Aging
Interventions
KUVAN, Placebo, Cetrotide, Climara, Placebo transdermal patch
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 70 Years · Female only
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2016
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Jul 11, 2019 · Synced Oct 2, 2026, 3:22 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan Nonresponders

NCT01274026
View directory record Official record
Conditions
Phenylketonuria, Behavior and Behavior Mechanisms, PAH Gene Expression
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
Tulane University School of Medicine
Other
Eligibility
2 Years to 21 Years
Enrollment
21 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2013
U.S. locations
1
States / cities
New Orleans, Louisiana
Source: ClinicalTrials.gov public record
Updated Aug 14, 2023 · Synced Oct 2, 2026, 3:22 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

The Brain and Neuropsychological Functioning in Adults With Sapropterin Dihydrochloride Treated Phenylketonuria

NCT02297347
View directory record Official record
Conditions
Phenylketonuria
Interventions
Not listed
Lead sponsor
Boston Children's Hospital
Other
Eligibility
18 Years to 55 Years
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2017
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 5, 2018 · Synced Oct 2, 2026, 3:22 PM EDT
Completed No phase listed Observational Accepts healthy volunteers Results available

Nutritional and Neurotransmitter Changes in PKU Subjects on BH4

NCT00688844
View directory record Official record
Conditions
Phenylketonuria
Interventions
KuvanTM Therapy
Drug
Lead sponsor
Emory University
Other
Eligibility
4 Years and older
Enrollment
58 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2010
U.S. locations
2
States / cities
Atlanta, Georgia • Decatur, Georgia
Source: ClinicalTrials.gov public record
Updated Jun 8, 2015 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 2 Interventional Results available

A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease

NCT00403494
View directory record Official record
Conditions
Intermittent Claudication
Interventions
Placebo, Sapropterin Dihydrochloride
Other · Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
40 Years to 80 Years
Enrollment
190 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
17
States / cities
Scottsdale, Arizona • Sacramento, California • San Diego, California + 14 more
Source: ClinicalTrials.gov public record
Updated Jan 7, 2021 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Early Phase 1 Interventional

Exercise and NO in HFrEF

NCT03136029
View directory record Official record
Conditions
Heart Failure With Reduced Ejection Fraction
Interventions
Antioxidant, Tetrahydrobiopterin (BH4), Exercise training
Dietary Supplement · Other
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years and older
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Aug 6, 2025 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 2 Interventional Results available

Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response

NCT00841100
View directory record Official record
Conditions
Phenylketonuria
Interventions
Kuvan, Diet
Drug · Other
Lead sponsor
University of Miami
Other
Eligibility
4 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Dec 3, 2019 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 3 Interventional Results available

Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006

NCT00332189
View directory record Official record
Conditions
Phenylketonuria
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
4 Years and older
Enrollment
111 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
14
States / cities
Los Angeles, California • Sacramento, California • San Jose, California + 11 more
Source: ClinicalTrials.gov public record
Updated Nov 16, 2012 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 2 Interventional Results available

A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction

NCT00532844
View directory record Official record
Conditions
Endothelial Dysfunction
Interventions
Sapropterin Dihydrochloride, Sapropterin Dihydrochloride and Vitamin C
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
18 Years to 75 Years
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
1
States / cities
Hackensack, New Jersey
Source: ClinicalTrials.gov public record
Updated May 17, 2021 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Exercise Intolerance in Renal Failure

NCT01356966
View directory record Official record
Conditions
Kidney Failure, Chronic
Interventions
Tetrahydrobiopterin, Placebo, Folate
Drug · Dietary Supplement
Lead sponsor
Emory University
Other
Eligibility
18 Years to 75 Years
Enrollment
74 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2014
U.S. locations
2
States / cities
Atlanta, Georgia • Decatur, Georgia
Source: ClinicalTrials.gov public record
Updated Jun 1, 2015 · Synced Oct 2, 2026, 3:22 PM EDT
Recruiting Phase 1 Interventional

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

NCT06312748
View directory record Official record
Conditions
Heart Failure With Preserved Ejection Fraction, Inflammation
Interventions
L-Citrulline, Placebo for L-Citrulline, BH4, Placebo for BH4, Atorvastatin, Placebo for Atorvastatin
Drug
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 23, 2026 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 4 Interventional Results available

The Effectiveness of Kuvan in Amish PKU Patients

NCT02677870
View directory record Official record
Conditions
Phenylketonuria
Interventions
saproterin dihydrochloride, Diet treatment
Drug · Other
Lead sponsor
University Hospitals Cleveland Medical Center
Other
Eligibility
2 Years to 60 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 27, 2022 · Synced Oct 2, 2026, 3:22 PM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

Response to Phenylketonuria to Tetrahydrobiopterin (BH4)

NCT00244218
View directory record Official record
Conditions
Phenylketonuria
Interventions
tetrahydrobiopterin (BH4)
Drug
Lead sponsor
The University of Texas Medical Branch, Galveston
Other
Eligibility
10 Years and older
Enrollment
57 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2005 – 2015
U.S. locations
1
States / cities
Galveston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 21, 2021 · Synced Oct 2, 2026, 3:22 PM EDT
Terminated Not applicable Interventional Accepts healthy volunteers Results available

A Pilot Study on Diurnal Variation

NCT01806051
View directory record Official record
Conditions
Phenylketonuria (PKU)
Interventions
Kuvan
Drug
Lead sponsor
Dr. Linda Randolph
Other
Eligibility
4 Years and older
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Apr 20, 2016 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease

NCT02774226
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
Tetrahydrobiopterin (BH4), Antioxidant Cocktail
Drug · Dietary Supplement
Lead sponsor
Augusta University
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2018
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Feb 23, 2021 · Synced Oct 2, 2026, 3:22 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

Sapropterin in Individuals With Phenylketonuria

NCT00730080
View directory record Official record
Conditions
Phenylketonuria
Interventions
Sapropterin (Kuvan)
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
6 Years to 50 Years
Enrollment
45 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2018
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jun 18, 2018 · Synced Oct 2, 2026, 3:22 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

The Effects of Kuvan on Functional Brain Connectivity in Individuals With Phenylketonuria (PKU)

NCT00964236
View directory record Official record
Conditions
Phenylketonuria
Interventions
Sapropterin
Drug
Lead sponsor
University of Missouri-Columbia
Other
Eligibility
6 Years and older
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2011
U.S. locations
1
States / cities
Columbia, Missouri
Source: ClinicalTrials.gov public record
Updated Jan 4, 2018 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment

NCT02530996
View directory record Official record
Conditions
Rheumatologic Disease
Interventions
BH4, Vasculopathy assessment, Placebo
Drug · Diagnostic Test
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years to 95 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2019
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 5, 2021 · Synced Oct 2, 2026, 3:22 PM EDT
Terminated Phase 2 Interventional Results available

Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction

NCT00802893
View directory record Official record
Conditions
Isolated Systolic Hypertension, Endothelial Dysfunction
Interventions
6R-BH4, Placebo
Drug · Other
Lead sponsor
Johns Hopkins University
Other
Eligibility
40 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 21, 2017 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Kuvan in People With Schizophrenia and Schizoaffective Disorder

NCT01706965
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder
Interventions
Kuvan, Multivitamin
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 64 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 13, 2017 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Early Phase 1 Interventional

Effects of Tetrahydrobiopterin on Blood Pressure

NCT00208780
View directory record Official record
Conditions
Hypertension
Interventions
Tetrahydrobiopterin
Drug
Lead sponsor
Emory University
Other
Eligibility
18 Years to 75 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Nov 18, 2013 · Synced Oct 2, 2026, 3:22 PM EDT
Active, not recruiting Phase 1 Interventional

The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

NCT04800692
View directory record Official record
Conditions
Claudication, Intermittent, Peripheral Artery Disease, Peripheral Vascular Diseases
Interventions
Tetrahydrobiopterin 10 mg/kg, Tetrahydrobiopterin 20 mg/kg, L-Ascorbate, L-Arginine
Drug
Lead sponsor
Louis Messina
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 15, 2026 · Synced Oct 2, 2026, 3:22 PM EDT
Completed Not applicable Interventional Results available

Tetrahydrobiopterin Treatment in Children With Idiopathic Cognitive Developmental Disorders

NCT01141595
View directory record Official record
Conditions
Autism Spectrum Disorder
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
2 Years to 6 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
1
States / cities
Little Rock, Arkansas
Source: ClinicalTrials.gov public record
Updated Apr 1, 2014 · Synced Oct 2, 2026, 3:22 PM EDT