At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 190 enrolled
Drug / intervention
Sapropterin Dihydrochloride +1 moredrug
Likely dose
Sapropterin Dihydrochloride 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease
In Brief
A Phase 2 clinical trial evaluating Placebo and Sapropterin Dihydrochloride for Intermittent Claudication. Completed, enrolled 190 participants across 20 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntermittent Claudication
CountriesArgentina, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2006
Enrollment StartDec 2006
Primary CompletionNov 2008
Study CompletionJan 2009
TodayJul 2026
First PostedNov 23, 2006
Enrollment StartDec 1, 2006
Primary CompletionNov 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.6 years ago
Interventions
Placeboother
Subjects receive matching oral Placebo twice daily for 24 weeks.
Sapropterin Dihydrochloridedrug
Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.