A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension
1 other identifier
interventional
84
1 country
24
Brief Summary
The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of poorly controlled hypertension in the presence or absence of type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hypertension
Started May 2006
Typical duration for phase_2 hypertension
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 11, 2006
CompletedFirst Posted
Study publicly available on registry
May 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJuly 21, 2009
July 1, 2009
7 months
May 11, 2006
July 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial systolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension.
Secondary Outcomes (4)
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial diastolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in insulin sensitivity after 8 weeks of treatment in subjects with both type 2 diabetes and poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in eNOS activity and endothelial dysfunction after 8 weeks of treatment in subjects with poorly controlled hypertension
To assess the safety of oral dosing of 6R-BH4 in subjects with poorly controlled hypertension
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures.
- 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.
You may not qualify if:
- Previous treatment with any formulation of BH4.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Hoover, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Gilbert, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Burbank, California, United States
Unknown Facility
Cudahy, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Auburn, Maine, United States
Unknown Facility
Scarborough, Maine, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Carrollton, Texas, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martha Nicholson, MD
BioMarin Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 11, 2006
First Posted
May 15, 2006
Study Start
May 1, 2006
Primary Completion
December 1, 2006
Study Completion
December 1, 2008
Last Updated
July 21, 2009
Record last verified: 2009-07