A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease

Summary

The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and effective in the treatment of intermittent claudication (IC) caused by peripheral arterial disease (PAD).

Timeline

Start

2006-12

Primary completion

2008-11

Completion

2009-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Sapropterin Dihydrochloride vs Placebo; p = 0.727; Mean Difference (Final Values) -0.021 (95% CI -0.138 to 0.097); t-test, 2 sided NCT00403494 ↗

Drugs

Indications