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Showing 1–24 of 30 matching trials from the live ClinicalTrials.gov search.
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
Completed Not applicable Interventional Accepts healthy volunteers Results available

Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)

NCT01398943
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Tetrahydrobiopterin (BH4), Antioxidant Cocktail
Drug · Dietary Supplement
Lead sponsor
Augusta University
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2015
U.S. locations
1
States / cities
Augusta, Georgia
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
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
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
Terminated Phase 1 Interventional Accepts healthy volunteers

Response to Phenylketonuria to Tetrahydrobiopterin (BH4)

NCT00244218
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
Terminated Phase 2 Interventional Accepts healthy volunteers Results available

Phenylketonuria, Oxidative Stress, and BH4

NCT01395394
Conditions
Phenylketonuria
Interventions
Kuvan, Meal Challenge
Drug · Other
Lead sponsor
Emory University
Other
Eligibility
10 Years to 45 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2013
U.S. locations
1
States / cities
Decatur, Georgia
Withdrawn Phase 1 Interventional Accepts healthy volunteers

O2 Transport and Utilization in Health and Lung Disease

NCT04014712
Conditions
COPD, Tetrahydrobiopterin Deficiency, Oxidative Stress
Interventions
Tetrahydrobiopterin, Placebo oral tablet
Drug
Lead sponsor
University of Massachusetts, Amherst
Other
Eligibility
18 Years to 85 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
Amherst, Massachusetts
Completed Phase 4 Interventional Results available

The Effectiveness of Kuvan in Amish PKU Patients

NCT02677870
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
Completed Phase 1Phase 2 Interventional Results available

Study of Kuvan Treatment in Adults With GTPCH Deficiency

NCT01425528
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
Completed Early Phase 1 Interventional Accepts healthy volunteers

Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

NCT02042196
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
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Exercise Intolerance in Renal Failure

NCT01356966
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
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
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
Completed Early Phase 1 Interventional

Exercise and NO in HFrEF

NCT03136029
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
Completed Phase 1Phase 2 Interventional Results available

Kuvan in People With Schizophrenia and Schizoaffective Disorder

NCT01706965
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
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
Conditions
Renal Insufficiency, Chronic
Interventions
6R-BH4, 6R-BH4 placebo, Folic acid, Exercise training, Stretching, Histidine and beta-alanine supplementation, Histidine and beta-alanine placebo
Drug · Other · Dietary Supplement
Lead sponsor
Emory University
Other
Eligibility
18 Years to 75 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2027
U.S. locations
3
States / cities
Atlanta, Georgia • Decatur, Georgia
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
Conditions
Phenylketonuria
Interventions
sapropterin dihydrochloride
Drug
Lead sponsor
BioMarin Pharmaceutical
Industry
Eligibility
Up to 6 Years
Enrollment
95 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
12
States / cities
La Jolla, California • Orange, California • Tampa, Florida + 9 more
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Cystic Fibrosis and Endothelial Function: At Rest and During Exercise

NCT01772758
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
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

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

NCT02530996
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
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
Completed Phase 1 Interventional Accepts healthy volunteers

The Effect of Antioxidants on Skin Blood Flow-BH4

NCT03680573
Conditions
Cardiovascular Diseases, Cardiovascular Risk Factor, Vasoconstriction
Interventions
Control: Lacated Ringers, Apocynin, Allopurinol, BH4, NG Nitro L Arginine Methyl Ester, Sodium Nitroprusside, Acetyl-ß-methylcholine chloride
Drug
Lead sponsor
The University of Texas at Arlington
Other
Eligibility
18 Years to 35 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Arlington, Texas