Trial Outcomes & Findings for Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction (NCT NCT00802893)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

4-6 weeks

Results posted on

2017-08-21

Participant milestones
Measure	All Participants 6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period OR Placebo: placebo given BID for entire length of study
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	All Participants 6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period OR Placebo: placebo given BID for entire length of study
Overall Study study terminated	3

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

Baseline characteristics by cohort
Measure	All Participants n=3 Participants 6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period OR Placebo: placebo given BID for entire length of study
Age, Customized >=40, years	3 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	3 Participants n=99 Participants

Timeframe: 4-6 weeks

Population: Due to difficulties recruiting, this study was terminated and no data was collected.

Outcome data not reported

Timeframe: 4-8 weeks

Population: Due to difficulties recruiting, this study was terminated and no data was collected.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Johns Hopkins University School of Medicine

Phone: 410-550-6484