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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: May 2009

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

Interventions

  • Drug: 6R-BH4
    • 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period
  • Other: Placebo
    • placebo given BID for entire length of study

Arms, Groups and Cohorts

  • Experimental: Experimental Drug
  • Placebo Comparator: Placebo Comparator

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function
    • Time Frame: 4-6 weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • BioMarin Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor

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