45 The study included an open-label lead-in phase of six weeks, a double-blind, randomized, placebo-controlled withdrawal phase of 12 weeks, and an open-label extension phase of 48 weeks or more.
Patients in our study had an average A1C >10% at enrollment and achieved an A1C reduction of 5% in the 3-month lead-in phase of the study using insulin and metformin.
The Sibutramine Cardiovascular OUTcomes (SCOUT) trial included 10 742 obese or overweight high-risk patients where all patients received 10 mg sibutramine hydrochloride monohydrate (sibutramine) once daily for six weeks during the single-blind, lead-in phase of the study.
The study was carried out in a phase I clinical trials unit and comprised a lead-in phase of 5 wk, an intervention phase of 6 wk, and a washout phase of 4 wk.
Within the clinical study report, summary tables of adverse events for some of the trial phases were presented; the lead-in phase of 3-10 days without drugs was always missing.
Boceprevir-based therapy included 4 weeks (lead-in phase) of Peg-IFN-α2b (1.5 μg/kg/week) or Peg-IFN-α2a (180 μg/week) and RBV (800 or 1,400 mg/day, depending on body weight), then 44 weeks of Peg-IFN-α2b/RBV and boceprevir (800 mg tid).
Two serious adverse events were reported in in the lead-in phase of the phase III study (MRA316JP): 45 one with anaphylaxis and one with gastrointestinal hemorrhage from colonic ulceration in a patient with previous history of diarrhea and rectal bleeding.
After a lead-in phase of three infusions of 4 mg zoledronic acid in the hospital setting, 101 patients were randomized to receive three open-label infusions in the community or hospital setting, followed by three infusions in the opposite venue (a total of nine infusions).
After a lead-in phase of intravenous injections at days 1, 3, and 7, ten rabbits were weekly injected with galactosylated poly- l-lysine pENTR214 (30 μg/kg body weight), and 9 animals received a scrambled control once a week (30 μg/kg body weight).
The BOC trial design included a 4-week lead-in phase of PegIFN and RBV and compared response-guided triple therapy (BOC plus PegIFN and RBV for 32 weeks; patients with a detectable HCV RNA level at week 8 received SOC for an additional 12 weeks) and a fixed duration of triple therapy given for 44 weeks (total 48 weeks of therapy), to SOC therapy.
The therapeutic program consisted of a single-blind placebo lead-in phase about the treatment of 10 drug-free subjects (5 27 years old) with autistic disorder.
