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Orlistat renal dose. The primary endpoint was change in the AUC (C max ) of the drug and was calculated by dividing the C max time of administration. Secondary outcomes were the time to onset of renal injury and the mean change in renal function. Study protocol This was a single-center randomized, double-blind, placebo-controlled study. Informed consent, approved by the institutional review board (IRB), was obtained from all participants. patients were enrolled and randomized by a statistician with minimal training, who was blinded to the dose or genotype and treatment assignment. Patients were enrolled between October 1996 and May 1997 at seven sites (Atlanta, Georgia; Birmingham, Alabama; Denver, Colorado; Houston, Texas; Los Angeles, California; and San Diego, California) in a population of 832 consecutive male and female patients who had no history of kidney disease or nephrotoxicity. The study was conducted initially in two parts: 1) a pretreatment, baseline, and posttreatment study (Phase 1) 2) an end-of treatment study (Phase 2). During Phase 1, the dose of simvastatin and genotype (C, G, T) of the study drug were controlled and identical to those used in Phase 1 of our previously published Phase I study (4). The total number of patients in each the three treatment categories was same: 12 male and female patients in the placebo and no change groups 12 male and female patients in the high-dose C or G groups and no change (Table 1). The study drug was a single-dose simvastatin tablet that included a 10% vitamin C solution that consisted of 50 mL mM HEPES solution. Table 1. Study Drug and Genotype Placebo-No Change Group A drugstore makeup sale C G T Placebo-No Change Group B C G T Placebo-No Change Group C G T Placebo-No Change Phase 1 12 4 2 6 Phase 3 12 10 11 8 Mean ± SD 4.2 2.0 4.3 1.9 3.3 ± 1.6 2.9 1.3 3.2 2.7 ± 3.3 1.6 Mean SD 4.7 ± 2.5 4.6 2.0 3.3 4.3 ± 2.8 3.8 2.4 3.6 2.5 4.1 ± 2.2 Open in a separate window The subjects were randomly assigned to receive simvastatin 20 mg, mg/d, mg/d/g, 50 or mg/d/g daily, beginning on day 0 and continuing until 90. Baseline characteristics and clinical outcomes were similar in placebo and both treatment conditions (Table 2). Phase 1 baseline data showed that the mean age of patients was 59 years. One patient in the placebo group (1.8%) was <60 years in age at baseline, compared with 14.2% of the participants in both treatment groups. The median (range) change from baseline in the primary endpoint was −8.3% (0.5 to 13.0%); the median (range) change in primary endpoint the high-dose C was −7.2% (0.2 to 11.8%; mean±SD), and the median (range) change in overall score was −12.9% (–8.9% to 6.0%) for the high- dose G group. mean (±SD) change in creatinine clearance was 14.6% (–1.9% to 43.8%) in the placebo-treated patients and 9.7% (–12.3% to 33.4%) in those Dove comprare viagra generico in italia treated with simvastatin 20 mg/d and 50 mg/d, respectively. The primary endpoint was measured daily for 7 d by measuring the AUC of drug and by means Cmax, the lowest concentration achieved during course of a single administration the drug, during first 7 d in all patients. The Cmax was expressed as lowest amount of drug in plasma that was detected by enzyme-linked immunosorbent assay (ELISA) after an initial washout period of 6 h and a second 24 washout before measurement. Table 2. Placebo Group No Change A C G T Placebo-No Change Group B C G T orlistat 120 mg rezeptfrei bestellen Placebo-No Change Group C G T Placebo-No Change on d 0 0.00 (−0.01) 0.09 (−0.14) 0.12 (−0.16) 12.6 (−4.1) 1.1 (−0.5) 0.
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