NCT00802893

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-12-05
• Last updated: 2017-08-21
• Results posted: 2017-08-21

Locations

1 site across 1 country: United States