ISH 001 Study

This study is closed. Thank you for your interest.

Principal Investigator Name: Susan Zieman, M.D. Ph.D

Study Coordinator Name: Barbara Peterson, RN, CCRC

Contact Phone: 410-955-9864

Contact: Study Coordinator Contact Phone

Contact E-mail: bpeter21@jhmi.edu

Contact: Study Coordinator Contact E-mail

Study Short Title: ISH-001

Study Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel Study of Oral 6R-BH4 in Subjexts with Isolated Systolic Hypertension and Endothelial Dysfunction (ISH-001)

IRB Number: NA 00014296

Funding Source: Gift Account

Brief Summary of Trial: Volunteers with Isolated Systolic Hypertension and Endothelial Dysfunction are needed for a 3 month study with oral 6R-BH4 (IRB # NA_00014296) We are enrolling men and women over the age of 40, with high blood pressure for a 3 month study designed to assess if twice dily oral dosing of 6R-BH4 vs. placebo imporoves endothelial dysfunction, reduces systolic blood pressure and reduces arterial stiffness in subjects with isolated systolic hypertension (ISH) and endothelial dysfunction Participation involves 10 visits at Johns Hopkins Hospital, including physical exams, echocardiograms, ECGs and labs. If eligible, volunteers will receive daily study medicine. Eligible volunteers will receive $20.00 per completed study visit, a parking voucher

Inclusions: To be in the study you must meet the following qualifications: 1. Male or female age 40 and older 2. Have high blood pressure

Exclusions: You cannot: 1. Be pregnant or breastfeeding or planning to become pregnant during the study. 1. Have heart failure 3. Have Atrial fibrillation 4. Have had a heart attack or stroke or surgery in the last 90 days 5. Have had Coronary artery bypass surgery within 6 months before screening 6. Be taking Methotrexate, Levodopa, Sildenafil, Tadalafil, Vardenafil, Cilostazol, milrinone or Vesnarinone 7. Some other exclusions may apply

Keywords: High Blood Pressure Isolated Systolic Hypertension Endothelial Dysfunction

Address for Clinical Trial Site: Johns Hopkins Hospital 600 N. Wolfe Street Baltimore, MD 21287

Compensation: Yes

Clinical Trial Start Date: Feb-08

Anticipated End Date: Feb-10