NCT00403494

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

A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: BioMarin Pharmaceutical · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intermittent Claudication

Interventions

Type	Name	Description
OTHER	Placebo	Subjects receive matching oral Placebo twice daily for 24 weeks.
DRUG	Sapropterin Dihydrochloride	Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-11-01
• Completion: 2009-01-01
• First posted: 2006-11-23
• Last updated: 2021-01-07
• Results posted: 2021-01-07

Locations

20 sites across 2 countries: United States, Argentina