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

August 17, 2017 updated by: Johns Hopkins University

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel Study of Oral 6R-BH4 in Subjects With Isolated Systolic Hypertension and Endothelial Dysfunction

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator
Other: Placebo
placebo given BID for entire length of study
Experimental: Experimental Drug
Drug: 6R-BH4
6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

BioMarin Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00014296

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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