Status and phase
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About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
At least 40 years and no more than 80 years old
A 6-month (or longer) history of walking limitation because of IC, severity of which has not changed in the past 3 months
Diagnosis of PAD secondary to atherosclerosis, with PAD documented at Screening by one of the following criteria:
On Gardner graded treadmill protocol, peak walking time (PWT) of at least 1 minute, but no more than 12 minutes
Variation in PWT between two consecutive screening treadmill tests less than or equal to 25%
If currently receiving treatment with or taking any of the following, willing and able to discontinue for 30 days before Screening and throughout the entire study (including the follow-up period): phosphodiesterase (PDE) 5 inhibitor (eg, Viagra®, Cialis®, Levitra®, or Revatio™), any PDE 3 inhibitor (eg, cilostazol, milrinone, or vesnarinone), pentoxifylline (Trental®), nitrates, L-arginine, ginkgo biloba, or Heart Bar
For the approximately 50% of subjects enrolled to receive vitamin C with study drug or placebo, subjects must be willing to discontinue taking vitamin C supplements or a multivitamin containing vitamin C during study.
Antihypertensive therapy, cholesterol-lowering therapy (eg, statins), and diabetic therapy (if applicable) has been stable for 30 days prior to Screening.
Has not changed smoking or exercise habits in 30 days prior to randomization and is unlikely to do so during the study period
Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures
Willing and able to comply with all study-related procedures
Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study
Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
190 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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