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The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either Cialis 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively.In male volunteers with CLcr = 50–80 mL/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with CLcr >80 mL/min. In male volunteers with CLcr = 30–50 mL/min or CLcr<30 mL/min renal impairment groups, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with CLcr>80 mL/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis. [See Dosage and Administration (2.3), Warnings and Precautions (5.9), and Use in Specific Populations (8.7).]
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