This lead-in period also served as a medication washout period for any patients taking non-statin lipid-altering medications such as niacin >200 mg daily, fibrates, fish oil, other products containing OM-3 fatty acids, or other herbal products or dietary supplements with potential lipid-altering effects at the time of screening (6-week washout was required for such patients).
Subjects were required to have an untreated mean IOP of at least 22 mmHg and <38 mmHg at <span class="lh">screening baseline visit after washout of medications.
Patients did not receive any phosphate binder medication during the 2-week washout phase that followed screening.
After screening and washout for up to 4 weeks, eligible participants meeting inclusion and exclusion criteria were randomized in a 1 1 ratio at baseline (week 0) to placebo (n=81) or optimized LDX 30, 50, or 70 mg/d (n=80) during a 10-week, double-blind treatment period.
After screening, patients were given a 2-week washout period for analgesics other than acetaminophen.
The study consisted of four visits: one screening visit, two clamp visits separated by a washout phase of 5 21 days, and one follow-up visit.
(The pain requirement at baseline following washout [≥50 mm] was greater than at screening [≥40 mm]; thus, an increase in pain from screening to baseline was required for study entry).
There was a washout period before screening and, following the screening visit, there was a 2-week run-in period prior to randomization to ensure clinical stability.
The decrease in HbA1c was similar between subjects who were not on an AHA at screening (52%) and those who underwent AHA washout.
After screening, subjects taking antidepressant medications at doses approved to treat depression underwent a washout period of up to two weeks, while those taking lower doses had the antidepressant stopped without a washout.
