Back to resultsOral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction
Primary Purpose
Isolated Systolic Hypertension, Endothelial Dysfunction
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
6R-BH4
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Isolated Systolic Hypertension focused on measuring Isolated Systolic Hypertension with Endothelial Dysfunction
Eligibility Criteria
Inclusion Criteria:
- No change in prescribed antihypertension medications within the previous 30 days
- Study staff able to visualize and measure the brachial artery diameter by high resolution vascular ultrasound required for FMD measurements
- ISH with the following mean seated BP: SBP > 145 and < 180 mmHg. Diastolic blood pressure < 90mmHg
Exclusion Criteria:
- Has known hypersensitivity to 6RBH4 or its excipients
- Pregnant or breastfeeding at screening
- Use of any investigational product or investigational medical device within 30 days prior to screening
- Current disease or condition that would interfere with study participation or safety such as the following: heart failure, atrial fibrillation, aortic valve disease, bleeding disorders, history of repeated syncope or vertigo, severe GERD, GI ulcer, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic disorders including seizures, organ transplant or organ failure
- Hypertension secondary to other medical conditions
- Any severe comorbid condition that would limit life expectancy to <6 months
- Current use of any nicotine containing substances
- History of drug or alcohol abuse
- MI, stroke or surgery within 90 days before Screening Visit
- CABG within 6 months before the Screening Visit
- Serum creatinine >2.0mg/dl or AST, ALT, GGT levels >2times upper limit of normal
- Concomitant treatment with: any drug known to inhibit folate metabolism, any phosphodiesterase-5 or -3 inhibitor
- Previous treatment with any formulation of BH4
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Drug
Placebo Comparator
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function
Secondary Outcome Measures
Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness
Full Information
NCT ID
NCT00802893
First Posted
December 4, 2008
Last Updated
August 17, 2017
Sponsor
Johns Hopkins University
Collaborators
BioMarin Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00802893
Brief Title
Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction
Official Title
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel Study of Oral 6R-BH4 in Subjects With Isolated Systolic Hypertension and Endothelial Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
We were unable to recruit any subjects into this study so no subjects completed the protocol. Therefore, we are unable to provide any conclusions.
Study Start Date
December 2008 (Actual)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
BioMarin Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4 to improve endothelial function, reduce systolic blood pressure and reduce arterial stiffness.
Detailed Description
By comparing values measured at different timepoints, the study is expected to provide insight regarding the ability of 6R-BH4, administered along with their currently prescribed antihypertension medications, to improve endothelial function, reduce SBP, and reduce arterial stiffness in patients with ISH and endothelial dysfunction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isolated Systolic Hypertension, Endothelial Dysfunction
Keywords
Isolated Systolic Hypertension with Endothelial Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Drug
Arm Type
Experimental
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
6R-BH4
Intervention Description
6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo given BID for entire length of study
Primary Outcome Measure Information:
Title
Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness
Time Frame
4-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
No change in prescribed antihypertension medications within the previous 30 days
Study staff able to visualize and measure the brachial artery diameter by high resolution vascular ultrasound required for FMD measurements
ISH with the following mean seated BP: SBP > 145 and < 180 mmHg. Diastolic blood pressure < 90mmHg
Exclusion Criteria:
Has known hypersensitivity to 6RBH4 or its excipients
Pregnant or breastfeeding at screening
Use of any investigational product or investigational medical device within 30 days prior to screening
Current disease or condition that would interfere with study participation or safety such as the following: heart failure, atrial fibrillation, aortic valve disease, bleeding disorders, history of repeated syncope or vertigo, severe GERD, GI ulcer, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic disorders including seizures, organ transplant or organ failure
Hypertension secondary to other medical conditions
Any severe comorbid condition that would limit life expectancy to <6 months
Current use of any nicotine containing substances
History of drug or alcohol abuse
MI, stroke or surgery within 90 days before Screening Visit
CABG within 6 months before the Screening Visit
Serum creatinine >2.0mg/dl or AST, ALT, GGT levels >2times upper limit of normal
Concomitant treatment with: any drug known to inhibit folate metabolism, any phosphodiesterase-5 or -3 inhibitor
Previous treatment with any formulation of BH4
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction
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