Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction

NCT ID: NCT00802893

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-05-31

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

Conditions

Isolated Systolic Hypertension; Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Drug

Group Type: EXPERIMENTAL

6R-BH4

Intervention Type: DRUG

6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo given BID for entire length of study

Interventions

6R-BH4

6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period

Intervention Type: DRUG

Placebo

placebo given BID for entire length of study

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMarin Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00014296

Identifier Type: -

Identifier Source: org_study_id