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

NCT00802893 | Terminated Phase 2 Results DMC

• 1 other identifier: NA_00014296
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Isolated Systolic Hypertension; Endothelial Dysfunction

Keywords

Isolated Systolic Hypertension with Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function

  4-6 weeks

Secondary Outcomes (1)

• Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness

  4-8 weeks

Study Arms (2)

Experimental Drug

EXPERIMENTAL

Drug: 6R-BH4

Placebo Comparator

PLACEBO COMPARATOR

Other: Placebo

Interventions

6R-BH4 DRUG

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

Experimental Drug

Placebo OTHER

placebo given BID for entire length of study

Placebo Comparator

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• BioMarin Pharmaceutical: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Isolated Systolic Hypertension

Interventions

sapropterin

Condition Hierarchy (Ancestors)

Essential Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Johns Hopkins University Clinical Trials Program
• Organization: Johns Hopkins University School of Medicine

registerclinicaltrials@jhmi.edu

410-550-6484

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 21, 2017
• Results First Posted: August 21, 2017

Record last verified: 2017-08

Locations

US (1)