A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension
NCT ID: NCT00325962
Last Updated: 2009-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2006-05-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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6R-BH4 (sapropterin dihydrochloride)
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age.
* Willing and able to comply with all study-related procedures.
* History of documented essential hypertension (BP greater than or equal to 140 mm Hg systolic and/or 90 mm Hg diastolic measured on 2 separate occasions).
* Have poorly controlled hypertension despite use of at least two conventional antihypertensive agents with different mechanisms of action taken concurrently and consistently for at least 3 months before randomization. (Note: Antihypertensive agents may be individual or combined into a single medication.)
* During the two-week screening period, mean SBP and mean DBP fall within the following ranges:
* Mean SBP between 135 and 160 mm Hg
* Mean DBP between 85 and 110 mm Hg
* Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study.
* Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during this study.
Individuals in the diabetic cohort must meet this additional criterion:
* Documented history of type 2 diabetes that has been treated using the same therapy for at least 3 months.
Exclusion Criteria
* Known allergy or hypersensitivity to any excipient of 6R-BH4.
* Known secondary cause for hypertension.
* Concurrent disease or condition that would interfere with study participation or safety such as bleeding disorders, history of syncope or vertigo, severe gastrointestinal reflux disease (GERD), symptomatic coronary or peripheral vascular disease, arrhythmia, organ transplant, organ failure, or type 1 diabetes mellitus.
* Any sever co-morbid condition that would limit life expectancy to less than 6 months.
* Serum creatinine \>2.0mg/dL or hepatic enzyme levels more than 2 times the upper limit of normal.
* Requirement for concomitant treatment with any drug known to inhibit folate metabolism (e.g., methotrexate).
* Concomitant treatment with levodopa.
* Concomitant treatment with any phosphodiesterase (PDE) 5 inhibitor (e.g., Viagra(R), Cialis(R), or Levitra(R), or Revatio (TM) or any PDE 3 inhibitor (e.g., cilostazol, milrinone, or vesnarinone).)
* Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
* Pregnant or breastfeeding at screening or planning to become pregnant (subject or partner) at any time during study.
18 Years
ALL
No
Sponsors
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BioMarin Pharmaceutical
INDUSTRY
Principal Investigators
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Martha Nicholson, MD
Role: STUDY_DIRECTOR
BioMarin Pharmaceutical
Locations
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Hoover, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Muscle Shoals, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Anaheim, California, United States
Burbank, California, United States
Cudahy, California, United States
Long Beach, California, United States
Roseville, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Indianapolis, Indiana, United States
Auburn, Maine, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Knoxville, Tennessee, United States
Carrollton, Texas, United States
Countries
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Related Links
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BioMarin Pharmaceutical Inc. website
Other Identifiers
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HTN-001
Identifier Type: -
Identifier Source: org_study_id
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