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

NCT00403494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2021-01-07

Study results available
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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).

Conditions

  • Intermittent Claudication

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Don Nwose, MD · BioMarin Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-11-30
Completion
2009-01-31

Countries

  • United States
  • Argentina

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00403494 on ClinicalTrials.gov