drugset / Trial / NCT00208780

Effects of Tetrahydrobiopterin on Blood Pressure

NCT00208780

RandomizedParallel-groupOpen-labelTreatment

Summary

Tetrahydrobiopterin (BH4) is a cofactor for the nitric oxide (NO) synthase enzymes, such that its insufficiency results in uncoupling of the enzyme, leading to release of superoxide rather than NO in disease states, including hypertension. We hypothesized that oral BH4 will reduce arterial blood pressure (BP) and improve endothelial function in hypertensive subjects. Oral BH4 was given to subjects with poorly controlled hypertension (BP \>135/85 mm Hg) and weekly measurements of BP and endothelial function made. In Study 1, 5 or 10 mg kg-1 day-1 of BH4 (n=8) was administered orally for 8 weeks, and in Study 2, 200 and 400 mg of BH4 (n=16) was given in divided doses for 4 weeks

Timeline

Start
2004-12
Primary completion
2005-12
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject sapropterin Unknown 5 mg/kg Oral
Subject sapropterin Unknown 10 mg/kg Oral
Subject sapropterin Unknown 100 mg Oral
Subject sapropterin Unknown 200 mg Oral

Indications