Conditions: Intermittent Claudication
Keywords: Intermittent Claudication IC Symptomatic Peripheral Arterial Disease Peripheral Arterial Disease PAD 6R-BH4 BH4 sapropterin dihydrochloride endothelial dysfunction Nitric Oxide NO
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 190
Healthy volunteers: no

Brief 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).

Detailed description:
This was a Phase 2, multicenter, multinational, prospective, randomized, double-blind, placebo-controlled, parallel study designed to assess the efficacy and safety of sapropterin dihydrochloride in subjects with intermittent claudication (IC) caused by peripheral arterial disease (PAD). Subjects who met initial screening criteria were monitored criteria and that dosages of permitted concomitant medications were stable.

Arms:
arm 1: Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks. arm 2: Subjects receive matching oral Placebo twice daily for 24 weeks.

Interventions: intervention 1: Placebo intervention 2: Sapropterin Dihydrochloride
Intervention descriptions: intervention 1: Subjects receive matching oral Placebo twice daily for 24 weeks. intervention 2: Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.

Protocol document: