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Sponsored by: |
BioMarin Pharmaceutical |
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Information provided by: | BioMarin Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00532844 |
This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: 6R-BH4 with vitamin C and 6R-BH4 alone.
Condition | Intervention | Phase |
---|---|---|
Endothelial Dysfunction |
Drug: 6R-BH4 (sapropterin dihydrochloride) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment |
Official Title: | A Phase 2, Randomized, Open-Label, 2-Treatment, 2-Sequence, 2-Period Crossover, Pharmacokinetic (PK) Study to Compare the Plasma Concentrations of BH4 in Subjects With Endothelial Dysfunction Following 14 Days of Treatment by Each of 2 Regimens: 6R-BH4 With Vitamin C and 6R-BH4 Alone |
Estimated Enrollment: | 40 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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6R-BH4: Experimental
6R-BH4 5 mg/kg BID for 13.5 days
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Drug: 6R-BH4 (sapropterin dihydrochloride)
5 mg/kg BID of 6R-BH4 tablets to be administered orally for 13.5 days
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6R-BH4 + Vitamin C: Experimental
6R-BH4 5 mg/kg BID + 500 mg Vitamin C BID for 13.5 days
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Drug: 6R-BH4 (sapropterin dihydrochloride)
5 mg/kg BID of 6R-BH4 tablets, plus 500 mg BID of Vitamin C caplets to be administered orally for 13.5 days
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If currently receiving treatment with or taking any of the following supplements, be willing and able to discontinue taking them throughout the treatment period:
Exclusion Criteria:
Concomitant treatment with:
United States, New Jersey | |
Recruiting | |
Hackensack, New Jersey, United States | |
Contact: Christina Campusano 415-506-6410 ccampusano@bmrn.com |
Study Director: | Saba Sile, MD | BioMarin Pharmaceutical |
Responsible Party: | BioMarin Pharmaceutical Inc. ( BioMarin Pharmaceutical Inc. ) |
Study ID Numbers: | HTN-002 |
Study First Received: | September 18, 2007 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00532844 |
Health Authority: | United States: Food and Drug Administration |
6R-BH4 BH4 BH4 deficiency sapropterin dihydrochloride endothelial dysfunction |
NO Hypertension Nitric Oxide Vitamin C |
Nitric Oxide Tetrahydrobiopterin deficiencies Ascorbic Acid Hypertension |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |